Control of Communicable Diseases
Federal RegisterJan 19, 2017
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Parts 70 and 71
[CDC Docket No. CDC-2016-0068]
RIN 0920-AA63
Control of Communicable Diseases
AGENCY:
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
ACTION:
Final rule.
SUMMARY:
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is issuing this final rule (FR) to amend its regulations governing its domestic (interstate) and foreign quarantine regulations to best protect the public health of the United States. These amendments have been made to aid public health responses to outbreaks of new or re-emerging communicable diseases and to accord due process to individuals subject to Federal public health orders. In response to public comment received, the updated provisions in this final rule clarify various safeguards to prevent the importation and spread of communicable diseases affecting human health into the United States and interstate.
DATES:
This rule is effective February 21, 2017.
FOR FURTHER INFORMATION CONTACT:
Director, Division of Global Migration and Quarantine, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-E03, Atlanta, GA 30329, or email
dgmqpolicyoffice@cdc.gov
.
SUPPLEMENTARY INFORMATION:
Based on public comment received to the Notice of Proposed Rulemaking (NPRM) (81 FR 54230) this final rule, among other things: Withdraws a provision regarding “Agreements” as proposed in the NPRM, requires CDC to issue a federal order within 72 hours after apprehending an individual, increases the threshold for those who may be considered “indigent” to 200% of the applicable poverty guideline, adds a definition for “Secretary,” adds a requirement for CDC to provide legal counsel for isolated or quarantined individuals qualifying as indigent who request a medical review, modifies the definition of “non-invasive,” includes “known or possible exposure” in the list of information that may be collected during a public health risk assessment, and strengthens due process protections by ensuring that CDC will arrange for translation or interpretation services for public health orders and medical reviews as needed. In implementing quarantine, isolation, or other public health measures under this Final Rule, HHS/CDC will seek to use the least restrictive means necessary to prevent the spread of communicable disease.
Table of Contents
I. Executive Summary
A. Purpose of the Action
B. Summary of Major Provisions
C. Summary of Costs and Benefits
II. Public Participation
III. Background
A. Legal Authority
B. Regulatory History
IV. Summary of the Final Rule
A. General References to “CDC” and “Director” in Parts 70 and 71
B. Definitions (§§ 70.1 and 71.1(b))
C. Apprehension and Detention of Persons With Quarantinable Communicable Diseases (70.6)
D. Medical Examinations (§§ 70.12 and 71.36)
E. Requirements Relating to the Issuance of a Federal Order for Quarantine, Isolation, or Conditional Release (§§ 70.14 and 71.37)
F. Mandatory Reassessment of a Federal Order for Quarantine, Isolation, or Conditional Release (§§ 70.15 and 71.38)
G. Medical Review of a Federal Order for Quarantine, Isolation, or Conditional Release (§§ 70.16 and 71.39)
H. Administrative Records Relating to a Federal Order for Quarantine, Isolation, or Conditional Release (§§ 70.17 and 71.29)
I. Payment for Care and Treatment (70.13 and 71.30)
J. Agreements (§§ 70.18 and 71.40)
K. Penalties (§§ 70.18 and 71.2)
L. Public Health Prevention Measures To Detect Communicable Disease (§§ 70.10 and 71.20)
M. Requirements Relating to Travelers Under a Federal Order of Isolation, Quarantine, or Conditional Release (§ 70.5)
N. Report of Death or Illness Onboard Aircraft Operated by an Airline (§ 70.11)
O. Requirements Relating to Collection, Storage, and Transmission of Airline and Vessel Passenger, Crew, and Flight and Voyage Information for Public Health Purposes (§§ 71.4 and 71.5)
P. Requirements Relating to Collection, Storage, and Transmission of Airline and Vessel Passenger, Crew, and Flight and Voyage Information for Public Health Purposes (§§ 71.4 and 71.5)
Q. Report of Death or Illness (§ 71.21)
V. Overview of Public Comment to the 2016 NPRM
A. Provisions Applicable to Both Parts 70 and 71
a. General Comments
b. Scope and Authority
c. Definitions
d. Public Health Prevention Measures To Detect Communicable Disease
e. Apprehension and Detention of Persons With Quarantinable Communicable Diseases
f. Medical Examinations
g. Requirements Relating to Issuance of a Federal Order for Quarantine, Isolation, or Conditional Release
h. Mandatory Reassessment of a Federal Order for Quarantine, Isolation, or Conditional Release
i. Medical Review of a Federal Order for Quarantine, Isolation, or Conditional Release
j. Administrative Records Relating to a Federal Order for Quarantine, Isolation, or Conditional Release
k. Other Due Process Concerns
l. Privacy
m. Payment for Care and Treatment
n. Agreements
o. Penalties
p. Economic Impact
q. Paperwork Reduction Act
B. Provisions Applicable to Part 70 Only (Domestic)
a. General
b. Requirements Relating to Travelers Under a Federal Order of Isolation, Quarantine, or Conditional Release
c. Report of Death or Illness Onboard Aircraft Operated by an Airline
C. Provisions Applicable to Part 71 Only (Foreign)
a. Requirements Relating to Transmission of Airline and Vessel Passenger, Crew, and Flight Information for Public Health Purposes
b. Suspension of Entry of Animals, Articles, or Things From Designated Foreign Countries and Places Into the United States
VI. Alternatives Considered
VII. Required Regulatory Analyses
A. Executive Orders 12866 and 13563
B. The Regulatory Flexibility Act
C. The Paperwork Reduction Act
D. National Environmental Policy Act (NEPA)
E. Executive Order 12988: Civil Justice Reform
F. Executive Order 13132: Federalism
G. The Plain Language Act of 2010
I. Executive Summary
A. Purpose of the Action
HHS/CDC has statutory authority (42 U.S.C. 264, 265) to promulgate regulations that protect U.S. public health from communicable diseases, including quarantinable communicable diseases as specified in an Executive Order of the President.
See
Executive Order 13295 (April 4, 2003), as amended by Executive Order 13375 (April 1, 2005) and Executive Order 13674 (July 31, 2014). The need for this rulemaking was reinforced during HHS/CDC's response to the largest outbreak of Ebola virus disease (Ebola) on record, followed by the recent outbreak of Middle East Respiratory Syndrome (MERS), both quarantinable communicable diseases, and repeated outbreaks and responses to measles, a non-quarantinable communicable disease of public health concern. This
final rule will enhance HHS/CDC's ability to prevent the introduction, transmission, and spread of communicable diseases into the United States and interstate by clarifying and providing greater transparency regarding its response capabilities and practices.
B. Summary of Major Provisions
Both the domestic and foreign portions of this regulation include new proposed public health definitions; new regulatory language implementing HHS/CDC's activities concerning non-invasive public health prevention measures (
i.e.,
traveler health screening) at U.S. ports of entry and other U.S. locations (
i.e.,
railway stations, bus terminals); and provisions affording due process to persons served with a Federal public health order (
e.g.,
isolation, quarantine), including requiring that HHS/CDC explain the reasons for issuing the order, administrative processes for appealing the order, and a mandatory reassessment of the order.
The domestic portion of this final rule includes a requirement that commercial passenger flights report deaths or illnesses to the CDC. It also includes a provision requiring that individuals apply for a travel permit if they are under a Federal quarantine, isolation, or conditional release order (unless the specific travel is authorized by the Federal conditional release order) or if a State or local public health department requests CDC assistance in enforcing a State or local quarantine or isolation order. Additionally, the domestic portion of this final rule includes new regulatory language clarifying when an individual who is moving between U.S. states is “reasonably believed to be infected” with a quarantinable communicable disease in a “qualifying stage.” These determinations are made when the CDC considers the need to apprehend or examine an individual for potential infection with a quarantinable communicable disease. The foreign portion of this final rule includes new regulatory authority permitting the CDC Director to prohibit the importation of animals or products that pose a threat to public health.
HHS/CDC has also changed the text of the regulation to reflect modern terminology, technology, and plain language used by private industry, public health partners, and the public. The final rule also authorizes public health monitoring through electronic or internet-based means of communication for individuals under a Federal conditional release order who are reasonably believed to be exposed to or infected with a quarantinable communicable disease. This would include communication through email and webcam application tools. Finally, while neither modifying nor authorizing additional criminal penalties for violations of quarantine rules and regulations, this final rule updates regulatory language to align with existing criminal penalties set forth in statute.
C. Summary of Costs and Benefits
The regulatory impact analysis quantitatively addresses the costs and benefits associated with this final rule. The economic impact analysis of this final rule is subdivided into two sections.
The first analysis summarizes the economic impact of changes to 42 CFR 70.1, 42 CFR 71.1/71.4/71.5 for which the primary costs for submitting passenger and crew information to HHS/CDC are incurred by airlines and vessel operators and the primary benefit is improved public health responsiveness to assess and offer post-exposure prophylaxis to travelers potentially exposed to communicable diseases of public health concern. The most likely estimates of annual costs to airlines, vessel operators, the United States government, and public health departments are low ($32,622, range $10,959 to $430,839) because the final rule primarily codifies existing practice or improves alignment between existing regulatory text and the International Civil Aviation Organization (ICAO)'s guidelines for symptoms to report. The cost estimates in this final rule are based on (1) an anticipated small increase in the number of illness reports delivered by airlines and processed by HHS/CDC and (2) increased costs for airlines and vessel operators to comply with HHS/CDC orders for traveler and crew contact data, to the extent that such information is readily available and already maintained, and not already transmitted to the U.S. Customs and Border Protection (CBP). The cost estimate also includes an increase in costs for public health departments to contact more exposed travelers due to the availability of improved contact data.
The best estimate of the annual quantified benefits of the final rule are $110,045 (range $26,337 to $297,393) and mostly result from increased efficiencies for HHS/CDC and State and local public health departments to conduct contact investigations among travelers on an aircraft exposed to communicable diseases of public health concern, especially for measles and tuberculosis. To the extent that improved responsiveness of airlines to HHS/CDC traveler data orders may result from the implementation of the provisions in this final rule, HHS/CDC may become better able to respond to infectious diseases threats and (1) reduce case-loads during infectious disease outbreaks, (2) reduce public anxiety during disease outbreaks, (3) mitigate economic impacts on businesses as a consequence of reduced public anxiety associated with quarantinable communicable disease outbreaks initiated by international travelers (such as have been observed during outbreak of severe acute respiratory syndrome in Canada or Middle East respiratory syndrome in South Korea), and (4) reduce the amount of personnel labor time to conduct large-scale contact investigations in response to a new infectious disease or one with larger scale public health and medical consequences like Ebola.
The second analysis in this final rule is of a number of provisions that aim to improve transparency of how HHS/CDC uses its regulatory authorities to protect public health. HHS/CDC believes that improving the quality of its regulations by providing clearer explanations of its policies and procedures is an important public benefit. However, HHS/CDC is not able to attach a dollar value to this added benefit in a significant way.
II. Public Participation
On August 15, 2016, HHS/CDC published a notice of proposed rulemaking (NPRM) (81 FR 54299) to amend 42 CFR part 70 (interstate) and 42 CFR part 71 (foreign) quarantine regulations. The public was invited to comment on these amendments. The comment period ended October 14, 2016. In the NPRM, HHS/CDC specifically requested public comment on the following:
• Whether the use of the standard definition of “indigent” is an appropriate threshold to determine whether an individual cannot afford representation and therefore should be appointed a medical representative at the government's expense and whether the public believes that there may be non-indigent individuals, as defined in the NPRM, who may have difficulty affording a representative;
• The definition of
public health emergency
and its utility in identifying communicable diseases that “would be likely to cause a public health emergency if transmitted to other individuals” under 42 U.S.C. 264(d)(2)(B);
• Requirements relating to travelers under a Federal order of isolation, quarantine, or conditional release; specifically, on whether stakeholders
have concerns regarding the requirement imposed on conveyance operators to not “knowingly” transport individuals under a Federal order and the feasibility of this requirement and the application of this provision to individuals under State/local order as well as individuals traveling entirely within a State.
• Public health prevention measures and whether the public has any concerns regarding the mandatory health screening of passengers using non-invasive means as defined in the proposal or the collection of personal information from screened individuals for the purposes of contact tracing;
• Payment for care and treatment, and whether there are any concerns that all third party payments be exhausted prior to the Federal reimbursement of medical care or treatment for individuals placed under a Federal order for quarantine, isolation, or conditional surveillance;
• The application of requirements relating to issuance of a Federal order for quarantine, isolation or conditional release as it applies to groups and whether this provision sufficiently informs the public of the important details concerning circumstances during which HHS/CDC would issue to groups or individuals Federal orders for quarantine, isolation, and conditional release and the duration and conditions of such orders;
• Whether 72 hours is the necessary amount of time to conduct a reassessment after a Federal order is first issued, or if the reassessment should take place earlier or later;
• Whether or not the public sees a role for the Federal government to ensure that basic living conditions, amenities, and standards are satisfactory when placing individuals under Federal orders;
• Whether the definition of “non-invasive” aligns with common perceptions of what constitutes non-invasive procedures that may be conducted outside of a traditional clinical setting;
• Whether the penalties proposed, and the circumstances under which such penalties may be imposed, were clearly explained;
• The applicability of the December 13, 2007 system of records notice (SORN) to the activities proposed (72 FR 70867), and whether the SORN sufficiently addresses the public's concerns related to maintenance and protection of the data elements proposed;
• The request for a passenger and crew manifest within 24 hours and whether the provision grants operators of airlines sufficient time for operators to respond to manifests orders;
• The likelihood that the passenger and crew data elements requested are already collected and maintained by airline operators for transmission to CDC;
• Any industry concerns regarding whether proposed section 71.63 sufficiently details the circumstances under which HHS/CDC may impose an embargo on the importation of animals, articles, or things, including how such an embargo would be implemented, as well as any concerns regarding coordination with other Federal agencies.
The public comment period for the proposed rule ended on October 14, 2016 and HHS/CDC received 15,800 comments from individuals, stakeholders, and groups. A summary of those comments and responses to those comments are found at Section IV, below.
II. Background
A. Legal Authority
The primary legal authorities supporting this rulemaking are sections 361 and 362
1
of the Public Health Service Act (42 U.S.C. 264, 265). HHS/CDC also believes that the following Public Health Service Act sections are relevant with respect to this rulemaking: section 311 (42 U.S.C. 243), section 321 (42 U.S.C. 248), section 322 (42 U.S.C. 249), section 365 (42 U.S.C. 268), and sections 367-69 (42 U.S.C. 270-72). A detailed explanation of these legal authorities was provided in the NPRM published at 81 FR 54230 (Aug. 15, 2016).
1
Section 3 of Executive Order 13295 (April 4, 2003) states that the functions of the President under sections 362 and 364(a) of the Public Health Service Act (42 U.S.C. 265 and 267(a) are assigned to the HHS Secretary.
B. Regulatory History
On August 15, 2016, HHS/CDC published a Notice of Proposed Rulemaking to update 42 CFR 70 (domestic) and 42 CFR 71 (foreign) quarantine regulations. These amendments were proposed to aid public health responses to outbreaks of communicable disease, such as the largest outbreak of Ebola virus disease (Ebola) on record, Middle East Respiratory Syndrome (MERS), both quarantinable communicable diseases, and repeated outbreaks of measles in the United States, a non-quarantinable communicable disease of public health concern. (81 FR 54299). Communicable diseases of public health concern are those diseases that because of their potential for spread, particularly during travel, may require a public health intervention. The provisions contained within the proposal were designed to enhance HHS/CDC's ability to prevent the further importation and spread of communicable diseases into the United States and interstate by clarifying HHS/CDC's response capabilities, practices, and making them more transparent.
III. Summary of the Final Rule
Upon consideration of public comment, the following is a section-by-section summary of the changes from the proposed text that HHS/CDC made to parts 70 and 71:
A. General References to “CDC” and “Director” in Parts 70 and 71
Throughout the regulatory text in parts 70 and 71, references to “CDC” or “HHS/CDC” have been replaced with “Director.” This is in keeping with the common practice that federal agencies act through employees and officials to whom the authority involved has been delegated.
Director
is currently defined in sections 70.1 and 71.1 to mean “the Director, Centers for Disease Control and Prevention, Department of Health and Human Services, or another authorized representative as approved by the CDC Director or the Secretary of HHS.” Where it is necessary to exclude CDC employees or officials from undertaking certain functions this has been indicated by use of parenthesis,
e.g.,
“Director (excluding the CDC official who issued the quarantine, isolation, or conditional release order).” This is a stylistic change from the NPRM, but does not result in a substantive change in the final rule.
B. Definitions (Sections 70.1 and 71.1(b))
• The definition of
Agreements
has been removed.
• The definition of
Electronic or internet-based monitoring
has been modified to include “communication through” these means and “audio” conference.
• The definition of
Indigent
has been modified to increase the threshold to 200% of the applicable poverty guidelines.
• The definition of
Ill person
under section 71.1 has been modified to include a person who “Has a fever that has persisted for more than 48 hours” or “Has acute gastroenteritis, which means either diarrhea, defined as three or more episodes of loose stools in a 24-hour period or what is above normal for the individual, or vomiting accompanied by one or more of the following: One or more episodes of loose stools in a 24-
hour period, abdominal cramps, headache, muscle aches, or fever (temperature of 100.4 °F [38°C] or greater).” This language was quoted verbatim in the preamble of the NPRM at 81 FR 54305 but was inadvertently omitted from the proposed regulatory text.
• The definition of
Medical Examination
has been modified to indicate that the health worker conducting the assessment must be “licensed.”
• The definition of
Medical Representative
has been changed to
Representatives
and now includes for an indigent individual the additional appointment of “an attorney who is knowledgeable of public health practices” if the indigent individual requests a medical review.
• The definition of
Non-invasive
has been modified to: (1) Replace “physical examination” with “visual examination;” (2) specify that the individual performing the assessment must be a “public health worker (
i.e.,
an individual with education and training in the field of public health)”; and (3) remove “auscultation, external palpation, external measurement of blood pressure.”
• A definition for
Secretary
has been added.
Secretary
means the Secretary of Health and Human Services (HHS) or any other officer or employee of that Department to whom the authority involved has been delegated. We note that while the NPRM did not propose this definition, the NPRM referenced the
Secretary
in defining
Public Health Emergency.
Thus, HHS/CDC considers it useful to also define the term
Secretary.
C. Apprehension and Detention of Persons With Quarantinable Communicable Diseases (Section 70.6)
This provision is has been finalized as proposed, with the exception that references to CDC have been replaced with Director throughout this section. HHS/CDC has also added a requirement that the Director arrange for adequate food and water, appropriate accommodation, appropriate medical treatment, and means of necessary communication, for individuals who are apprehended or held in quarantine or isolation. Similar language has been added to an analogous provision at Section 71.33(a).
D. Medical Examinations (Sections 70.12 and 71.36)
These provisions are finalized as proposed, with the exception that references to CDC have been replaced with Director throughout this section. HHS/CDC has also added a requirement that the Director, as part of the Federal order, advise the individual that the medical examination shall be conducted by an authorized and licensed health worker with prior informed consent.
E. Requirements Relating to the Issuance of a Federal Order for Quarantine, Isolation, or Conditional Release (§§ 70.14 and 71.37)
Paragraphs (a)(5) and (a)(4) of these provisions have been modified, respectively, to require that the Federal order include an explanation that the Federal order will be reassessed no later than 72 hours after it has been served and an explanation of the right to request a medical review, present witnesses and testimony at the medical review, and to be represented at the medical review by either an advocate (
e.g.,
an attorney, family member, or physician) at the individual's own expense, or, if indigent, to have representatives appointed at the government's expense. Paragraph (b) of these provisions has been modified to require that a Federal public health order be served within 72 hours of an individual's apprehension. Paragraph (c) has been modified to require that the Director arrange for translation or interpretation services of the Federal order as needed. References to CDC have been replaced with Director throughout this section.
F. Mandatory Reassessment of a Federal Order for Quarantine, Isolation, or Conditional Release (§§ 70.15 and 71.38)
These provisions have been modified to include paragraph (g) which states that the Director shall arrange for translation or interpretation services of the Federal order as needed. References to CDC have been replaced with Director throughout this section.
G. Medical Review of a Federal Order for Quarantine, Isolation, or Conditional Release (§§ 70.16 and 71.39)
Paragraph (f) of these provisions has been modified to reference “Representatives,” consistent with the change in definition. Paragraph (f) of these provisions has also been modified to remove, “and cannot afford a medical representative” because this language is duplicative and unnecessary if the individual has already qualified as indigent. Paragraph (k) of these provisions has been modified to state: “The medical review shall be conducted by telephone, audio or video conference, or through other means that the medical reviewer determines in his/her discretion are practicable for allowing the individual under quarantine, isolation, or conditional release to participate in the medical review.” These provisions have also been modified to include paragraph (q) which states that the Director shall arrange for translation or interpretation services as needed for purposes of this section. References to CDC have been replaced with Director throughout this section.
H. Administrative Records Relating to a Federal Order for Quarantine, Isolation, or Conditional Release (§§ 70.17 and 71.29)
These sections have been modified to remove paragraphs (5) regarding agreements between CDC and the individual.
I. Payment for Care and Treatment (§§ 70.13 and 71.30)
These provisions have been finalized as proposed, with the exception that references to CDC have been replaced with Director throughout this section.
J. Agreements (§§ 70.18 and 71.40)
These provisions have been removed.
K. Penalties (§§ 70.18 and 71.2)
The content of these provisions has been finalized as proposed. Proposed § 70.19
Penalties
has been moved to § 70.18, since proposed § 70.18
Agreements
has been removed from this final rule.
L. Public Health Prevention Measures To Detect Communicable Disease (§§ 70.10 and 71.20)
Paragraph (b) has been modified to include “known or possible exposure” information to the list of information that may be collected. References to CDC have been replaced with Director throughout this section.
M. Requirements Relating to Travelers Under a Federal Order of Isolation, Quarantine, or Conditional Release (Section 70.5)
Paragraph (a), (a)(4), (b)(1), (b)(2), and (c) of this provision have been modified to remove “agreements.” Paragraph (d) has been modified to add “to individuals traveling entirely intrastate and to conveyances that may transport such individuals.” The language in paragraph (d) was discussed in the NPRM at 81 FR 54243 and public comment concerning intrastate application of this provision was explicitly solicited. The language, however, was inadvertently omitted from the regulatory text. References to CDC have also been replaced with Director throughout this section. In response to public comments, HHS/CDC
has included a requirement that the Director respond to a request for a travel permit within five (5) business days and to an appeal under this section within three (3) business days. Public comments concerning this provision are addressed below.
N. Report of Death or Illness Onboard Aircraft Operated by an Airline (§ 70.11)
This provision has been finalized as proposed, with the exception that references to CDC have been replaced with Director throughout this section.
O. Requirements Relating to Transmission of Airline and Vessel Passenger, Crew, and Flight and Voyage Information for Public Health Purposes (§ 71.4 and 71.5)
These provisions have been finalized as proposed, with the exception that the title has been modified to remove references to collection and storage of information to more accurately reflect the requirements under this section and references to CDC have been replaced with Director throughout this section.
P. Suspension of Entry of Animals, Articles, or Things From Designated Foreign Countries and Places Into the United States (§ 71.63)
This provision has been finalized as proposed with the exception that references to CDC have been replaced with Director throughout this section.
Q. Report of Death or Illness (§ 71.21)
The title of this provision has been finalized as proposed, to remove the word “Radio.”
V. Overview of Public Comments to the 2016 NPRM
On August 15, 2016 HHS/CDC published a Notice of Proposed Rulemaking proposing to amend the current interstate (domestic) and foreign quarantine regulations for the control of communicable diseases. The NPRM included a 60-day public comment period and during this time, HHS/CDC received 15,800 comments from individuals, groups, organizations, industry, and unions. Comments were both in support of and in opposition to the regulation. Many public comments expressed concern that these updated regulations sought to compel medical treatment or vaccination without patient consent. One association stated its strong objection “to the coercive imposition of treatment, including vaccination, without the genuine consent of the patient.”
HHS/CDC begins this section by stating that these regulations do not compel vaccination or involuntary medical treatment. In keeping with current practice, HHS/CDC will continue to recommend care and treatment, including post-exposure prophylaxis when indicated, to individuals who are either sick with or at risk of disease following exposure to a communicable disease of public health concern.
HHS/CDC also received comments relating to immigration policy and regulations, issues of citizenship, border security, religion, personal testimony regarding adverse vaccine events, and requests to apply these regulations only to individuals who are not citizens of the United States. These comments are beyond the scope of this final rule and have not been included in this discussion. However, HHS/CDC notes that it will continue to apply communicable disease control and prevention measures uniformly to all individuals in the United States, regardless of citizenship, religion, race, or country of residency.
HHS/CDC also received public comment regarding disinsection (
i.e.,
measures to control or kill insect vectors of disease) and fumigation procedures, citing HHS/CDC's statutory authorities relating to inspection, fumigation, and pest extermination. We note that while HHS/CDC maintains regulations at 42 CFR 70.2 and 71.32(b) implementing this statutory authority, such comments are outside of the scope of this final rule, which did not include proposed changes to these regulatory provisions.
The following is a discussion of public comments received that are applicable and within the scope of the regulation. Topics including: Accountability, Administrative Records, Agreements, Apprehension, Authority (including Scope), Conditional Release, Constitutional Issues (including Amendments, Court Cases, and Habeas Corpus), Data Collection, Definitions, Detention, Due Process, Economic Impact, Electronic Monitoring, Exposure, Informed Consent, Least Restrictive Means, Minors, Medical Assessments, Examination, Notice, Penalties, Privacy, Qualifying Stage, Quarantine, Quarantinable Communicable Diseases List, and others are discussed.
A summary of comments and a response to those comments are found below, organized by general and specific comments that apply to both parts 70 and 71, comments that only apply to part 70 (interstate), and comments that only apply to part 71 (foreign).
A. Provisions Applicable to Both Parts 70 and 71
a. General Comments
Since posting the proposed regulation on August 15, 2016, HHS/CDC received 15,800 public comments. HHS/CDC received several comments from individuals, groups, or industry requesting to extend the 60-day comment period. In light of the number of comments submitted, HHS/CDC has determined that a 60-day comment period was both fair and sufficient to adequately inform the public of the contents of this rulemaking, allow the public to carefully consider the rulemaking, and receive informed public feedback. Thus, HHS/CDC declines to reopen the comment period.
Several commenters requested that HHS/CDC withdraw the NPRM in its entirety. A non-profit organization stated that the “NPRM would be, if adopted, a direct and onerous infringement of the personal liberties of Americans and an unnecessary aggressive method of assisting in the control of communicable disease.” Another commenter said that the “NPRM is premature.” HHS/CDC disagrees and declines to withdraw the proposal in its entirety because it contains important measures that will aid the public health response to prevent the introduction, transmission, and spread of communicable diseases into and within the United States. Moreover, in the spirit of transparency, these measures, which are largely current practice, are being published and codified to make the public aware of their use.
HHS/CDC received a comment from a partnership of public health legal scholars and organizations stating that it should promulgate a separate rule guaranteeing humane conditions of confinement. HHS/CDC disagrees that such a separate rule is needed and believes that the current final rule adequately addresses these concerns, as discussed in detail below.
HHS/CDC received a comment that the proposed rule does not comply with Executive Order 12866 because there is no public need for the rule and it did not adequately assess the costs and benefits of the rule, including the alternative of not regulating. HHS/CDC disagrees. As discussed in detail below, this rule describes the public health measures that may be used in response to outbreaks of communicable diseases, such as the recent largest recorded outbreak of Ebola. The economic impact analysis has been clarified to more clearly differentiate quarantinable and non-quarantinable diseases. The
economic impact analysis also examines the costs and benefits of the Final Rule measured against current practices (
i.e.,
a status quo baseline). Both the costs and benefits of this Final Rule are small because the provisions set forth are primarily a codification of current practices, based on existing regulatory authorities.
A public health research center commented that there is no evidence that measures employed at points of entry were effective during the response to the 2014-2016 Ebola outbreak and that HHS/CDC is attempting to codify these ineffective practices for use in future disease outbreaks. They further noted that despite greater than 99% complete monitoring, zero cases of Ebola were detected among those monitored. HHS/CDC appreciates this comment and recognizes the challenges presented by measuring the benefits of prevention in public health.
HHS/CDC disagrees that the measures employed in response to the 2014-16 Ebola outbreak were ineffective and that it is seeking to codify ineffective measures. HHS/CDC considers more than 99% complete monitoring a successful effort in State and Federal cooperation in response to an unprecedented outbreak of Ebola. Second, rather than the number of cases detected, HHS/CDC considers the key metrics of effectiveness to be the number of people who were able to continue to travel safely without fear of disease spread and the ability to facilitate rapid isolation and evaluation of the approximately 1400 individuals who developed illness compatible with Ebola during the 21-day monitoring period. Finally, we note that this commenter limited his or her statement to HHS/CDC measures put into place at U.S. ports of entry during the Ebola response.
The enhanced public health risk assessment protocol put into place at U.S. ports of entry in response to the Ebola outbreak was one part of a layered risk mitigation program to prevent the importation and spread of Ebola within the United States, which included exit screening in the affected countries as recommended by the World Health Organization (WHO) (see Statement on the 1st meeting of the International Health Regulations [IHR] Emergency Committee on the 2014 Ebola outbreak in West Africa 8/8/2014) and a reliance on air industry partners for detection and reporting of potentially ill travelers prior to arrival.
The enhanced entry risk assessment process was instituted after an individual infected with Ebola entered the United States and transmitted the disease. This case demonstrated that the processes then in place to prevent departure of individuals exposed to or infected with Ebola in affected West African countries could not detect persons who were exposed but were unaware of or denied such exposure and were potentially incubating the infection. To further reduce the risk of introduction and spread, HHS/CDC recommended monitoring of all potentially exposed individuals by a public health authority through the 21-day risk period after potential exposure, rather than relying on previously recommended self-monitoring. Monitoring was viewed as the least restrictive alternative to widespread quarantine and travel bans demanded by some members of the public that would ultimately have hampered the response efforts in West Africa and domestically. HHS/CDC, along with its Federal and State partners, implemented an entry process by which individuals identified as having recently traveled to, from, or through an affected country entered through five ports of entry where public health staff and partners were stationed, submitted accurate and complete contact information, were checked for symptoms, and were provided answers to Ebola risk assessment questions.
This was done for several reasons:
• To ensure that any individual entering the United States who could have been exposed to or infected with Ebola in a country experiencing an Ebola outbreak was identified and reported to the State and local health department of final destination so that, if the individual became ill, State or local health departments could rapidly notify healthcare providers prior to the individual's arriving at a hospital. This process was designed specifically to prevent unknowing individuals from exposing others such as occurred in Texas when a patient exposed two healthcare workers.
• While HHS/CDC acknowledges that a public health worker may be unlikely to encounter someone with symptoms at the moment of entry because of the 21-day incubation period, individuals coming from the outbreak countries frequently traveled for well over 24 hours and in many cases had itineraries that involved interstate movement within the United States. The odds of developing symptoms during that travel, and potential onward travel, were considered non-trivial, and public health measures to detect symptoms upon entry were considered warranted given the serious morbidity and costs associated with Ebola.
• The risk assessment at the limited ports of entry provided an important opportunity for HHS/CDC to stratify the risk of developing Ebola for every individual who entered from the affected countries. It allowed HHS/CDC to work with State and local health departments in implementing the least restrictive means of monitoring individuals for development of symptoms. HHS/CDC notes that there were no Federal quarantine orders issued because of the availability of monitoring options provided by State and local authorities under the
Interim U.S. Guidance for Monitoring and Movement of Persons with Potential Ebola Virus Exposure.
• The encounter also provided an opportunity to provide travelers with educational materials, orientate them to the monitoring program (Check and Report Ebola (CARE)), and facilitate reporting of the traveler's health status to State and local health departments.
The enhanced entry risk assessment and monitoring process described above was developed in response to the epidemiological profile of Ebola and the complexities of a 21-day incubation period. However, in the event of an outbreak of a different communicable disease requiring enhanced assessment or monitoring of travelers (whether quarantinable or non-quarantinable), HHS/CDC, in concert with Federal and State partners, may implement a different system of risk assessment and monitoring. HHS/CDC would tailor the program in accordance with the scientific evidence of the situation and the utility and feasibility of the program given the availability of resources.
The same public health research center commented that employing non-evidence-based measures is contrary to the United States' international legal agreements, specifically mentioning the public health measures implemented during the response to Ebola as they pertain to the International Health Regulations (IHR 2005). The commenter further stated that given the absence of evidence to support the use of travel monitoring and quarantine, HHS/CDC should proceed cautiously before employing these measures in the future.
Having addressed the commenter's concern regarding the evidence of the effectiveness of public health measures at ports of entry above, HHS/CDC concurs with the commenter that the use of quarantine and travel restrictions, in the absence of evidence of their utility, is detrimental to efforts to combat the spread of communicable disease. However, HHS/CDC disagrees that it used non-evidence based measures in contravention of the IHR.
To the contrary, HHS/CDC used the best available science and risk assessment procedures in designing a port of entry risk assessment and management program that took into account available resources, circumstances in the countries with Ebola outbreaks, and principles of least restrictive means to successfully ensure that measures to ban travel between the United States and the affected countries were unnecessary. These measures would have negatively impacted the efforts to combat Ebola in the region and would have had dramatic negative implications for travelers and industry.
Furthermore, the measures did not unduly affect travel or trade beyond the voluntary changes made by industry and travelers. HHS/CDC believes that CDC's entry risk assessment and management program was appropriate, commensurate with the risk, and consistent with the following WHO recommendation: “[Member] States should be prepared to detect, investigate, and manage Ebola cases; this should include assured access to a qualified diagnostic laboratory for Ebola and, where appropriate, the capacity to manage travelers originating from known Ebola-infected areas who arrive at international airports or major land crossing points with unexplained febrile illness.”
WHO Statement on the 1st meeting of the IHR Emergency Committee on the 2014 Ebola outbreak in West Africa
(Aug. 8, 2014). Travelers were assessed for risk on an individual basis upon entry; and any individual who met the pre-defined symptom threshold (based on exposure level) was medically evaluated and referred to care as needed. No Federal quarantine orders were issued for the duration of the response because HHS/CDC in coordination with State and local public health authorities was able to tailor its interventions to allow onward travel.
Future outbreaks may necessitate a different combination of public health measures at ports of entry. In those circumstances, HHS/CDC will use the best available science to assess the risk of importation and spread within the United States.
One commenter suggested that if HHS/CDC were to apply the “Precautionary Principle,” it would not promulgate these regulations. HHS/CDC notes first that the “precautionary principle,” often described as the avoidance of harm when there is scientific uncertainty about risks, originated in environmental contexts and remains largely associated with environmental issues. Invoking the precautionary principle in an environmental context, for instance, places the onus on those considering a potentially harmful action, such as drilling or mining near a watershed, to prove its safety in advance. The principle may be used by policy makers to justify discretionary decisions in situations where there is the possibility of harm from making a certain decision (
e.g.
taking a particular course of action) when extensive scientific knowledge on the matter is lacking.
HHS/CDC disagrees that this regulation will have harmful effect or that these measures lack a scientific basis for protecting public health. In fact, as described above regarding the response efforts to the 2014-2016 Ebola response, HHS/CDC has successfully employed the measures outlined in this regulation for many years. Again, the provisions outlined through this regulation are not new practices, nor new authorities, but a codification of HHS/CDC practice to protect public health.
One commenter suggested that education on healthy practices would be more effective than regulatory provisions. Another commenter stated that our immune systems would ward off communicable disease if we encourage clean water, adequate shelter, effective sewage treatment, and nutritious food. HHS/CDC agrees that these necessities are important to public health, and we rely on health communication often to educate the public on how to protect themselves and others from certain communicable diseases. For example, HHS/CDC routinely advises people with seasonal influenza to stay home from work and school, to cover their coughs and sneezes, and to wash their hands. HHS/CDC also works with State, local, and airport authorities in posting health education materials for the public. However, in certain circumstances, when a communicable disease poses a severe health threat to others, additional measures may be needed to protect the public's health. This is particularly important in situations when the infectious individual has disregarded public health recommendations by, for example, refusing to take prescribed medications to treat infectious tuberculosis or traveling while infectious. In such situations, it may be necessary to use public health authorities to require the individual to remain in isolation or to prevent travel to protect the public's health.
HHS/CDC received a few comments suggesting that publication of the NPRM in the
Federal Register
was not sufficient to inform the public of these proposed updates. One comment questioned why the proposed regulations were not more widely disseminated through media outlets. In response, HHS/CDC notes that Federal courts have long recognized that publication in the
Federal Register
is legally sufficient for giving affected persons notice of proposed rulemaking.
See Federal Crop Ins. Corp.
v.
Merrill,
332 U.S. 380, 385 (1947) (“Congress has provided that the appearance of rules and regulations in the
Federal Register
gives legal notice of their contents.”). The
Federal Register
, within the National Archives and Records Administration, is the official publication for all Federal agency rules, proposed rules, and notices of Federal agencies and organizations, as well as for Executive Orders and certain other presidential documents. Individuals interested in obtaining more information regarding HHS/CDC's regulatory processes, including input provided by persons and organizations, may examine the regulatory docket or submit a request through the Freedom of Information Act.
HHS/CDC received a comment stating that HHS/CDC should, by regulation, provide sufficient public health justification for screening practices to support its proposed public health prevention measures at ports of entry. While HHS/CDC agrees that it should provide sufficient public health justification for large-scale screening practices, HHS/CDC disagrees that this justification should be formalized in regulations. During the 2014-2016 Ebola epidemic, HHS/CDC issued
Interim U.S. Guidance for Monitoring and Movement of Persons with Potential Ebola Virus Exposure
to assist HHS/CDC staff and public health partners engaged in the response. The guidance provided public health authorities and partners with recommendations for monitoring people potentially exposed to Ebola and for evaluating their intended travel, including the application of movement restrictions when necessary. From August 2014-December 2015, the guidance was accessed online approximately 334,000 times, with more than 88,000 views during the first 4 days after the October 2014 update that added recommendations for active monitoring and clarified travel and movement restriction recommendations. Updates to the guidance to accommodate new information and changes in the outbreak situation continued through 2015. The guidance was retired on February 19, 2016, when more than 45 days had passed since Guinea was declared free of Ebola virus transmission, signaling widespread human-to-human transmission in the
affected countries was at an end. Formalizing this guidance in regulation would have deprived HHS/CDC of the needed flexibility to respond to public health events as they occurred, would have proved administratively burdensome and unnecessary, and would have potentially delayed prevention measures therefore resulting in a less effective response. HHS/CDC will consider the need for similar guidance during future outbreaks taking into account the extent of the outbreak and the risk of importation and spread of disease into the United States.
HHS/CDC received several comments suggesting that the proposed regulations were not written in plain language and were therefore difficult to understand. One commenter also noted errors in the document such as hyperlinks, references, and footnotes. This commenter also reviewed the NPRM for inconsistencies, conflicts, missing definitions, misleading language, and ambiguities. HHS/CDC thanks these commenters for the input. We have developed communication materials and published them to our Web site to help facilitate the review and comprehension of these documents. Interested persons should see
http://www.cdc.gov/quarantine/notice-proposed-rulemaking-control-communicable-diseases.html
.
One commenter opposed the rule because of a perceived negative social impact upon individuals placed under a public health order. We respond that one compelling reason for the publication of this final rule is to make the public aware of these measures so that the words, purposes, and meanings of “quarantine” and “isolation” become more familiar and less likely to cause public anxiety and stigmatization.
HHS/CDC received comments suggesting that, to best prevent the introduction of communicable diseases into the U.S., individuals who travel to or originate in countries with high risk of communicable disease should not be allowed to enter (or return to) the United States. On March 27, 2015, HHS/CDC published a Notice in the
Federal Register
titled
Criteria for Recommending Federal Travel Restrictions for Public Health Purposes, Including for Viral Hemorrhagic Fevers. See
80 FR 16400 (Mar. 27, 2015). The Notice describes the tools the Federal government has to ensure that people who pose a public health risk do not board flights or enter the United States without a public health evaluation.
See
80 FR 16400 (Mar. 27, 2015). It is the policy of HHS/CDC to work with the Department of State, and any other relevant Federal and State agencies to ensure infected U.S. citizens seeking to return to the U.S. do so in a manner that does not place the public at risk.
A few commenters expressed concern, as parents or guardians, about their rights with respect to children or minors. Specifically, these commenters wondered whether children/minors would be separated from parents/guardians during a public health risk assessment. HHS/CDC thanks the commenters for these questions and appreciates the opportunity to respond. In response, HHS/CDC notes that these regulations do not limit the rights that parents or guardians may have over minor children, including the right to make medical decisions. Notwithstanding, children are included in the definition of “individuals” as used in these regulations and thus minor children may be subject to apprehension, detention, examination, and conditional release for quarantinable communicable diseases to the same extent as adults. In such rare circumstances, HHS/CDC will work with the child's parent or guardian to ensure that the rights accorded to any individual subject to Federal isolation or quarantine, such as the opportunity for an administrative medical review, are adequately protected.
In addition, and in keeping with standard public health practice, parents or guardians while in the presence of infected minor children may be required to adhere to infection control precautions for their own protection. Such protections may include wearing personal protective equipment (such as a mask) while in close proximity to the child/minor to avoid further transmission of the illness. In extremely rare circumstances, such as a child infected with Ebola, the risk may be too great to allow a parent to remain with a child; however, every effort will be made to facilitate communication between a parent and a minor child through the least restrictive means, for example, through the use of technology.
One commenter asked about HHS/CDC obtaining the consent of a parent or legal guardian prior to the medical examination, quarantine, or treatment of minors. We respond that HHS/CDC will adhere to all applicable laws regarding the medical examination or treatment of minors. If minors are traveling unaccompanied by a parent or legal guardian and are believed to be infected with or exposed to a quarantinable communicable disease, HHS/CDC will use its best efforts to contact a parent or guardian to obtain consent prior to medical examination. In addition, HHS/CDC will not restrict a minor's ability to communicate with family or legal counsel hired by the minor's parent or legal guardian. As explained further below, HHS/CDC will appoint representatives, including a medical representative and an attorney, if the individual (including a minor's parent or legal guardian) is indigent and requests a medical review. HHS/CDC clarifies, however, that the public health measures included in this final rule, including apprehension, examination, quarantine, and isolation, do not require a parent or legal guardian's consent as a prerequisite to their application. However, in response to concerns about informed consent, HHS/CDC has added regulatory language requiring that the Director advise the individual that if a medical examination is required as part of a Federal order that the examination will be conducted by an authorized and licensed health worker with prior informed consent.
b. Scope and Authority
HHS/CDC received comments from the public questioning whether HHS/CDC is a part of the Federal government and has the authority to propose and promulgate regulations, or whether the Agency is a private entity. The “Communicable Disease Center” became part of the U.S. Public Health Service on July 1, 1946 and is an Agency within the U.S. Department of Health and Human Services. For more information on the history of CDC, please see
http://www.cdc.gov/museum/timeline/index.html
.
HHS/CDC received numerous comments from the public seeking clarity on the scope of authority the Agency has to take actions described in this regulation. Specifically, HHS/CDC received comments questioning whether the authority to detain an individual may be exercised by a Federal agency of government, instead of the U.S. President or Congress. Several commenters specifically questioned whether the wording of the regulation was too “general” and expressed concern over its potential for abuse. A public health organization recommended that HHS/CDC's authority should be limited only to those diseases listed by Executive Order as quarantinable communicable diseases. An association suggested that the proposed rule would vastly increase the authority of HHS/CDC. One individual stated that this regulation is an attempt by HHS/CDC to evade Congress. One organization speculated that HHS/CDC plans to request that the list of quarantinable communicable diseases be expanded “to include measles and other vaccine targeted diseases for the purpose of
apprehending and quarantining travelers entering the US or traveling between States, who have not been vaccinated with MMR (measles-mumps-rubella vaccine) and other Federally recommended vaccines.”
In response, HHS/CDC first notes that it cannot—and will not—act beyond the scope of authority granted by Congress in statute; HHS/CDC offers the following clarifications. Under section 361(a) of the Public Health Service Act (42 U.S.C. 264(a)), the HHS Secretary is authorized to make and enforce regulations as in the Secretary's judgment are necessary to prevent the introduction, transmission, or spread of all communicable diseases from foreign countries into the States or possessions of the United States and from one State or possession into any other State or possession. Under section 361(b)(42 U.S.C. 264(b)), the authority to issue regulations authorizing the apprehension, examination, detention, and conditional release of individuals is limited to those communicable diseases specified in an Executive Order of the President,
i.e.,
“quarantinable communicable diseases.” The authority for carrying out these regulations has been delegated from the HHS Secretary to the CDC Director, who in turn delegated these authorities to HHS/CDC's Division of Global Migration & Quarantine (DGMQ). These quarantinable communicable diseases are currently limited to cholera, diphtheria, infectious tuberculosis (TB), plague, smallpox, yellow fever, and viral hemorrhagic fevers (such as Marburg, Ebola, Lassa fever, and Crimean-Congo), severe acute respiratory syndromes, and influenza caused by novel or re-emergent influenza viruses that are causing or have the potential to cause a pandemic.
See
Executive Order 13295 (April 4, 2003), as amended by Executive Order 13375 (April 1, 2005) and Executive Order 13674 (July 31, 2014). Changes to the list of quarantinable communicable diseases are beyond the scope of this regulation. And again, we reemphasize that HHS/CDC does not intend, through these regulations, to mandate vaccination or compulsory medical treatment of individuals.
One commenter supported the international proposals (part 71), but urged HHS/CDC to remove the domestic portion (part 70) of this regulation. We disagree. HHS/CDC's authorities apply to all travelers in the United States, regardless of citizenship or residency, and are intended to complement State authorities within their jurisdictions by providing a mechanism to prevent importation of communicable disease from other countries as well as spread of communicable disease between States and between States and territories. Thus, HHS/CDC's and States' authorities together create a comprehensive system to protect the public from communicable disease threats including in situations such as interstate travel when a single State's authorities may be inadequate to address the communicable disease threat.
Several commenters suggested that HHS/CDC has the authority to unilaterally change or update the list of quarantinable communicable diseases. Other commenters requested that the list be narrowed to only those diseases with a “high mortality rate.” HHS/CDC reemphasizes that, as prescribed by statute, the list of quarantinable communicable diseases may only be changed by Executive Order of the President and that such suggestions are beyond the scope of this final rule.
HHS/CDC received several comments on the Agency's accountability system, encouraging that a “strong system of checks and balances” should be in place for this regulation to be implemented. HHS/CDC agrees that there should be accountability and oversight regarding the agency's activities. We note that these regulations do not affect the ability of Congress to conduct its oversight activities or affect the jurisdiction of federal courts to review federal agency actions under the Administrative Procedure Act (5 U.S.C. 704).
HHS/CDC received a comment that there is no court supervision of HHS/CDC activities. We disagree. These regulations do not affect the jurisdiction of the Federal courts or the statutory rights of individuals to obtain judicial review of CDC's actions and decisions through appropriate mechanisms such as the habeas corpus statute (28 U.S.C. 2241) or the Administrative Procedure Act (5 U.S.C. 704).
Some commenters questioned the need for HHS/CDC to use its authorities if the threat of death is minimal compared with the size of the population, listing illnesses such as chickenpox, pertussis, Zika, the common cold and flu, and leprosy. One organization suggested that, through the language of the NPRM, HHS/CDC was “equating” non-quarantinable diseases with quarantinable diseases. Another commenter suggested that HHS/CDC's authority to act should be based on the mortality of the illness, rather than whether or not it appears on the list of quarantinable communicable diseases. HHS/CDC thanks the commenters for consideration of the proposal as well as the input provided.
First, we note that HHS/CDC only has authority to quarantine or isolate individuals who have illnesses that are listed by Executive Order of the President as quarantinable communicable diseases. HHS/CDC does not have the ability or authority to unilaterally modify the list of quarantinable communicable diseases. Second, because HHS/CDC also has statutory authority to prevent the “introduction, transmission, and spread” of communicable diseases, HHS/CDC may take actions other than quarantine or isolation to protect the public's health. These other actions may include contact tracing investigations to notify individuals to seek proper treatment if they have been exposed to a communicable disease, even if the disease is not listed by Executive Order as quarantinable. HHS/CDC does not seek to compel vaccination or medical treatment. In keeping with current practice, HHS/CDC recommends certain vaccines for post-exposure prophylaxis and individuals may choose to follow these recommendations as they deem appropriate.
Other commenters questioned why diseases such as Ebola, measles, and Zika—three very different diseases with three very different effects on individuals—are used to support the same regulatory provisions. One organization quoted the NPRM, citing correctly that while measles is not a quarantinable communicable disease, it was used in the NPRM to support the need for this updated regulation. HHS/CDC welcomes the opportunity to provide further clarification.
The proposed rule provides HHS/CDC with a number of options for public health interventions based on a public health risk assessment of the communicable disease in question and the situation at hand. These interventions could include conducting a contact investigation on an airplane or vessel if a person with a serious communicable disease was known to have traveled on the airplane or vessel. These contact investigations are similar to those conducted by health departments in community settings. In addition to these interventions, for the nine communicable diseases currently designated by Executive Order as quarantinable communicable diseases, HHS/CDC may apprehend, detain, examine, quarantine, isolate, or conditionally release individuals for purposes of preventing communicable disease spread. Ebola and infectious tuberculosis are examples of quarantinable communicable diseases.
HHS/CDC also provides the public with recommendations to address other communicable diseases of public health concern. Zika is a good example of a disease of public health concern because of the ways it can be spread,
e.g.,
through mosquitoes, sexual transmission, and maternal-fetal transmission. Therefore, HHS/CDC has recommended avoiding mosquito bites, protecting against sexual transmission, and for pregnant women to avoid travel to areas where Zika is spreading. Another example is seasonal influenza, which is very contagious but also very common; therefore, HHS/CDC makes recommendations for people sick with flu-like symptoms to stay home from work or school and take basic precautions such as covering their coughs and sneezes and washing their hands. In all situations, HHS/CDC considers how common and severe the communicable disease is, how it is transmitted, and what interventions are available and appropriate before making recommendations or taking action to protect the health of the public.
One commenter questioned why HHS/CDC was not able to currently control all communicable diseases, specifically leprosy. While HHS/CDC works regularly and continuously with other Federal, State, local and tribal health departments to eliminate the introduction, transmission and spread of all communicable disease, outbreaks can and do still occur. HHS/CDC staff have experienced first-hand the impact of globalization on public health. The rapid speed and tremendous volume of international and transcontinental travel, commerce, and human migration enable microbial threats to disperse worldwide in 24 hours—less time than the incubation period of most communicable diseases. These and other forces intrinsic to modern technology and ways of life favor the emergence of new communicable diseases and the reemergence or increased transmission of known communicable diseases.
HHS/CDC received many comments regarding measles and the need to apply public health measures to prevent the transmission and spread of the disease. We note also that while measles may be transmissible during travel, it is not one of the quarantinable communicable diseases listed by Executive Order of the President. Therefore, while HHS/CDC may recommend post-exposure prophylaxis, or other ways to manage and prevent spread, we do not have the authority to apprehend, examine, detain, or conditionally release individuals who may have measles, nor those who may have been exposed.
See
80 FR 16,400 (Mar. 27, 2015)(describing air travel restrictions that may be applicable to a passenger who would represent a threat to public health).
HHS/CDC believes that requesting that DHS restrict the air travel of persons with measles is warranted because measles is a serious and highly contagious communicable disease that would pose a public health threat during travel. People exposed to measles who are not immune to the infection and have not been vaccinated following the exposure are advised to delay their travel voluntarily until they are no longer at risk of becoming infectious.
A number of commenters suggested that the proposed regulations are unconstitutional or in violation of the “Nuremberg Code,” the United Nations Educational, Scientific and Cultural Organization (UNESCO), the Universal Declaration on Bioethics and Human Rights, the Geneva Convention, human rights in general, and/or civil liberties in general because they ostensibly authorize compulsory medical treatment without informed consent. Commenters also cited numerous Supreme Court cases purportedly in support of these claims, such as
Mills
v.
Rogers,
457 U.S. 291 (1982), (curtailing the involuntary administration of anti-psychotic drugs to mental patients);
Vacco
v.
Quill,
521 U.S. 793 (1997) (constitutionality of an assisted suicide ban);
Washington
v.
Harper,
494 U.S. 210 (1990) (involuntary administration of anti-psychotic drugs to prison inmates);
Sell
v.
United States,
539 U.S. 166 (2003)(upholding certain strict due process protections before any involuntary administration of anti-psychotic drugs to incarcerated prisoners can be made); and
Canterbury
v.
Spence,
409 U.S. 1064 (1972)(duty of doctors to obtain informed consent). HHS/CDC disagrees and re-asserts that this final rule does not authorize compulsory medical treatment, including compulsory vaccination, without informed consent.
These regulations do not violate or take away any recognized rights guaranteed by the U.S. Constitution or applicable international agreements. While HHS/CDC has successfully responded to outbreaks of communicable diseases, such as Ebola, these regulations will improve HHS/CDC's future ability to prevent the introduction, transmission, and spread of communicable diseases, through such mechanisms as improved reporting of illnesses and public health prevention measures at airports. While many of these activities have been carried out in the past through internal operating procedures, these regulations improve the public's awareness and understanding of HHS/CDC's activities to protect the public's health.
One commenter expressed concerns about religious exemptions for mandatory vaccination or treatment. In response, HHS/CDC notes that these regulations do not authorize compulsory vaccinations or medical treatment. While HHS/CDC will implement these regulations in a manner consistent with respecting the religious rights of individuals, religion is not a basis for exempting individuals from the provisions of these regulations, including those provisions relating to quarantine and isolation.
One commenter raised similar concerns that the regulations may lead to apprehensions based on factors unrelated to public health such as wearing of religious garb or reading of certain newspapers. HHS/CDC agrees that public health actions should not be taken based on factors unrelated to protecting the public's health and these regulations do not authorize such actions. Additionally, these regulations strike the appropriate balance between individual liberties and public health protection.
Several commenters questioned whether quarantine and isolation may be carried out consistent with the Fourth Amendment to the U.S. Constitution. One commenter also suggested that implementation of public health prevention measures at airports would lead to “unreasonable searches and seizures” under the Fourth Amendment. HHS/CDC disagrees with these assertions. The Fourth Amendment protects the rights of persons to be free in their persons, houses, papers, and effects, against unreasonable government searches and seizures. HHS/CDC notes that at ports of entry, routine apprehensions and examinations related to quarantine and isolation may fall under the border-search doctrine, which provides that, in general, searches conducted by CBP officers at the border are not subject to the requirements of first establishing probable cause or obtaining a warrant.
See United States
v.
Roberts,
274 F.3d 1007, 1011 (5th Cir. 2001);
see also United States
v.
Bravo,
295 F.3d 1002, 1006 (9th Cir. 2002) (noting that only in circumstances involving extended detentions or intrusive medical examinations have courts required that border searches be premised upon reasonable suspicion). Similarly, apprehensions and examination of persons traveling interstate under this rule are authorized under the special-needs doctrine articulated by the
Supreme Court in
Skinner
v.
Railway Labor Executives' Ass'n,
489 U.S. 602 (1989) because of the “special need” in preventing communicable disease spread. Furthermore, to the extent that “probable cause,” rather than “special needs,” would be the applicable Fourth Amendment standard, HHS/CDC contends that meeting the requirements of 42 U.S.C. 264 satisfies this standard.
See Villanova
v.
Abrams,
972 F.2d 792, 795 (7th Cir.1992)(noting that probable cause for emergency civil commitment exists where “there are reasonable grounds for believing that the person seized is subject to the governing legal standard.”). HHS/CDC further acknowledges that any searches and seizures of individuals must be reasonable under the circumstances. HHS/CDC reiterates that this final rule does not authorize compulsory medical treatment, including vaccination, without informed consent.
HHS/CDC received a comment citing
Missouri
v.
McNeely,
where the U.S. Supreme Court ruled that police must generally obtain a warrant before subjecting a drunken-driving suspect to a blood test, and that the natural metabolism of blood alcohol does not establish a
per se
exigency that would justify a blood draw without consent. In response, HHS/CDC notes that courts have recognized that while the requirements for probable cause and a warrant generally apply in a criminal context, these standards do not apply when the government is conducting a non-law enforcement related activity.
See Nat'l Treasury Employees Union
v.
Von Raab,
489 U.S. 665 (1989) (reaffirming the general principle that a government search may be conducted without probable cause and a warrant when there is a special governmental need, beyond the normal need for law enforcement). HHS/CDC reiterates that the special-needs doctrine articulated by the Supreme Court in
Skinner
v.
Railway Labor Executives' Ass'n.,
489 U.S. 602 (1989) provides the appropriate legal standard under the Fourth Amendment for apprehensions and detentions under this final rule.
Several commenters also questioned whether the regulations are consistent with the requirements of the Fifth and Sixth Amendments to the U.S. Constitution. We note at the outset that the Sixth Amendment only applies to criminal proceedings and thus would be inapplicable to isolation and quarantine decisions which are public health protection measures unrelated to the normal needs of law enforcement. Furthermore, HHS/CDC asserts that this final rule is consistent with the requirements of due process embodied in the Fifth Amendment to the U.S. Constitution. Specifically, procedural safeguards contained in the final rule include: (1) A requirement for written orders of quarantine, isolation, or conditional release, including translation or interpretation services as needed; (2) mandatory review of the Federal order after the first 72 hours; (3) notifying individuals through the written order of their right to request a medical review; (4) an opportunity at the medical review for the detained individual to be heard through an attorney or other advocate hired at their own expense, present experts or other witnesses, submit documentary or other evidence; and confront and cross-examine any government witnesses; (5) a decision-maker independent of those who authorized the original isolation, quarantine, or conditional release; (6) a written statement by the fact-finder of the evidence relied upon and the reasons for the decision; (7) appointment of representatives, including a medical representative and an attorney, if the individual is indigent and requests a medical review; and (8) timely notice of the preceding rights.
See Vitek
v.
Jones,
445 U.S. 480 (1980);
Matthews
v.
Eldridge,
424 U.S. 319 (1976).
HHS/CDC also received a comment that quarantine violates the guarantees of substantive due process under the 5th Amendment to the U.S. Constitution. HHS/CDC disagrees. In addition to a guarantee of fair procedures, the U.S. Supreme Court has interpreted the Fifth Amendment's Due Process Clause as containing a substantive component barring certain arbitrary, wrongful government actions regardless of the fairness of the procedures used to implement them.
See Zinermon
v.
Burch,
494 U.S. 113, 125 (1990). HHS/CDC notes that the quarantine of individuals who have been exposed to a communicable disease, but are not yet capable of transmission is a well-known and accepted public health strategy of long standing.
See Jacobson
v.
Massachusetts,
197 U.S. 11, 25 (1905) (recognizing the power of States to issue “quarantine laws and health laws of every description”);
Compagnie Francaise de Navigation a Vapeur
v.
State Bd. of Health, Louisiana,
186 U.S. 380, 396 (1902) (discussing the 1893 Federal quarantine statute). The restrictions on individuals authorized under this regulation are justified by the benefits to the public health.
HHS/CDC received a comment that quarantine and isolation are State police powers that should not be exercised at the Federal level. While HHS/CDC acknowledges that the States have primary authority for quarantine and isolation within their borders, the Federal government has an important and longstanding role in preventing communicable disease spread at ports of entry and interstate. This authority is reflected in 42 U.S.C. 264 and consistent with principles of Federalism.
HHS/CDC received one comment stating that it should conduct a Federalism analysis because implementing the rule will require working with State health officials and resources. Under Executive Order 13132, a Federalism analysis is required if a rulemaking has federalism implications, would limit or preempt State or local law, or imposes substantial direct compliance costs on State or local governments. Under such circumstances, a Federal agency must consult with State and local officials. Federalism implications is defined as having substantial direct effects on State or local governments, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Under 42 U.S.C. 264(e), Federal public health regulations do not preempt State or local public health regulations, except in the event of a conflict with the exercise of Federal authority. Other than to restate this statutory provision, this rulemaking does not alter the relationship between the Federal government and State/local governments as set forth in 42 U.S.C. 264. While HHS/CDC acknowledges that portions of this rule may involve HHS/CDC “working with State health officials” to better coordinate public health responses, the rule is consistent with 42 U.S.C. 264(e) and there are no provisions that impose direct compliance costs on State and local governments. The longstanding provision on preemption in the event of a conflict with Federal authority (42 CFR 70.2) is left unchanged by this rulemaking. Therefore, HHS/CDC believes that the rule does not warrant additional consultation under Executive Order 13132.
HHS/CDC received several questions asking who would be responsible for the enforcement of these regulations. One commenter questioned whether HHS/CDC would use “militarized police or create [an] armed Federal police force to carry out these actions.” As explained elsewhere, in keeping with current practice and existing law, law enforcement support for quarantine or isolation orders will generally be provided by U.S. Customs and Border Protection, U.S. Coast Guard, or other Federal law enforcement programs, but
HHS/CDC may also accept voluntary State and local assistance in enforcing its Federal orders. HHS/CDC will also continue to enforce its regulations in a manner consistent with the Fourth Amendment and other provisions of the U.S. Constitution.
c. Definitions
Agreements
HHS/CDC received many comments on the definition of
Agreement,
largely expressing confusion and concern that such agreements would not be truly voluntary. The intent of this provision was to provide HHS/CDC with an additional tool to facilitate cooperation from individuals in regard to recommended public health actions. In response to public comments, however, HHS/CDC has withdrawn this definition and will not issue the proposed provisions on “Agreements.”
Airline
HHS/CDC did not receive public comment on the proposed definition of
Airline.
However, consistent with HHS/CDC's intent that this definition apply to common air carriers, to improve clarity, we have removed the phrase “including scheduled or public charter passenger operations operating in air commerce within the United States” and removed the reference to 49 U.S.C. 40102(a)(3).
Apprehension
HHS/CDC received many comments on the proposed definition and provision regarding
Apprehension;
a discussion of these comments is in the section below titled, “Apprehension and Detention of Persons with Quarantinable Communicable Diseases.” The definition is finalized as proposed.
Commander
HHS/CDC did not receive public comment on the proposed definition of
Commander.
Therefore, this definition is finalized as proposed.
Communicable Stage
HHS/CDC received a comment seeking clarity regarding the definition of
Communicable Stage.
The commenter stated that the definition for
communicable stage
may unnecessarily restrict social distancing powers because it appears limited to human-to-human transmission and does not include human transmission via an intermediate vector, such as mosquitoes or flea bites. HHS/CDC disagrees. The definition of communicable stage includes transmission of an infectious agent either “directly or indirectly from an infected individual to another individual.” Thus, HHS/CDC clarifies that indirect transmission of an infectious agent may include transmission via an insect vector as described by the commenter. This definition is finalized as proposed.
Conditional Release
HHS/CDC received many comments on the proposed definition and provision regarding
Conditional Release;
a substantive discussion of these comments is presented in the section below titled
Requirements Relating to Issuance of a Federal Order for Quarantine, Isolation, or Conditional Release.
HHS/CDC is modifying the definition of
Conditional Release
under section 70.1 to remove the cross-reference to the definition of surveillance as that term appears in current section 71.1. The definition of
Conditional Release
under section 70.1 tracks the definition of surveillance under section 71.1 and means “the temporary supervision by a public health official (or designee) of an individual or group, who may have been exposed to a quarantinable communicable disease to determine the risk of disease spread and includes public health supervision through in-person visits, telephone, or through electronic or internet-based monitoring.” HHS/CDC is making this change to improve clarity and remove the need for the public to cross-reference the definition of surveillance to understand the definition of
Conditional Release
as used in section 70.1.
This definition of
Conditional Release
under section 71.1 is finalized as proposed.
Contaminated Environment
HHS/CDC did not receive public comment on the proposed definition of
Contaminated Environment.
Therefore, this definition is finalized as proposed.
Conveyance
HHS/CDC did not receive public comment on the proposed definition of
Conveyance.
Therefore, this definition is finalized as proposed.
Electronic or Internet-Based Monitoring
HHS/CDC received many comments on the proposed definition and provision regarding
Electronic or Internet-based monitoring.
We have modified this definition as follows: “mechanisms or technologies allowing for the temporary public health supervision of an individual under conditional release and may include
communication through
electronic mail, SMS texts, video or audio conference, webcam technologies, integrated voice-response systems, or entry of information into a web-based forum; wearable tracking technologies; and other mechanisms or technologies as determined by the Director or supervising State or local health authority.”
Several commenters expressed privacy concerns because conditional release of exposed or ill individuals may be accomplished over the internet or through electronic monitoring. Other commenters expressed concerns about privacy, having misunderstood the proposed rule as authorizing HHS/CDC to conduct invasive surveillance of personal communications such as emails, text messages, and telephone calls. Commenters also expressed concerns related to the use of webcams and wearable tracking technologies as an option for monitoring of exposed people. One association viewed this proposed provision as an expansion of CDC's “electronic monitoring of personal information, under the guise of protecting the public against rare, isolated outbreaks of disease.”
HHS/CDC appreciates the opportunity to address these concerns. CDC's intent was to describe mechanisms that HHS/CDC or other public health authorities can use to communicate with individuals for the purpose of conducting monitoring following exposure to a quarantinable communicable disease. These mechanisms are intended as alternatives to in-person interviews because of the inconvenience and logistical problems that may arise when meeting in-person.
During the 2014-2016 Ebola response, HHS/CDC recommended “active monitoring” defined as daily communication between public health authorities and the individuals being monitored. HHS/CDC did not specify how this communication should occur, and health departments used a variety of electronic technologies for this purpose including those listed in the regulation. HHS/CDC also recommended “direct active monitoring” for people with certain higher levels of exposure. This involved having a public health official check in with the person through direct observation rather than relying on phone calls or electronic communications. Webcams were used by some health departments as an alternative to in-person visits to observe the person taking his or her temperature. The webcam was only operational during this scheduled public health “visit.” The use of webcams proved convenient for both
the health departments and the people being monitored, especially if the people lived in remote areas. Webcams are also used routinely by health departments for “directly observed therapy” for diseases like tuberculosis (TB), in order to watch patients take their TB medications. HHS/CDC has clarified the regulatory text to state that these technologies will be used for communicating with the individual and not as a means of monitoring the individual's personal communications.
One commenter asked whether HHS/CDC would “assist with payment for internet services” if webcam communications was required. In keeping with current practice, if an individual does not have access to internet services, HHS/CDC may use alternative methods to assist with communication, such as the issuance of a cellular phone. Some organizations also expressed concerns about the use of technologies such as cellular phones or wearable tracking technologies for the purpose of electronic monitoring. HHS/CDC acknowledges that the use of wearable tracking technology may be necessary in rare situations when a person does not comply with the required monitoring or when it is necessary to know the physical whereabouts of the person to ensure that they are not in a public place. While HHS/CDC acknowledges that public health surveillance of ill or exposed individuals through electronic monitoring may raise some privacy concerns, HHS/CDC believes that protecting the public's health outweighs these concerns.
HHS/CDC is committed to protecting the privacy of personally identifiable information collected and maintained under the Privacy Act of 1974. As detailed in the preamble of the proposed rule, on December 13, 2007, HHS/CDC published a notice of a new system of records under the Privacy Act of 1974 for its conduct of activities under this final rule (72 FR 70867). HHS/CDC accepted public comment on its proposed new system of records at that time. As required under the Privacy Act, HHS/CDC described in its notice the proposed system of records, the purpose for the collection of the system data, the proposed routine uses (
i.e.,
disclosures of system data that are compatible to the purpose for the data collection), the benefits and need for the routine use of this data, our agency's policies, procedures, and restrictions on the routine use disclosure of this information, and, most importantly, our safeguards to prevent its unauthorized use.
Under this system of records, CDC will only release data collected under this rule and subject to the Privacy Act to authorized users as legally permitted. HHS/CDC will take precautionary measures including implementing the necessary administrative, technical and physical controls to minimize the risks of unauthorized access to medical and other private records. In addition, HHS/CDC will make disclosures from the system only with the consent of the subject individual or, in accordance with the routine uses published at 72 FR 70867, or as allowed under an exception to the Privacy Act. Furthermore, HHS/CDC will apply the protections of the SORN to all travelers regardless of citizenship or nationality. Finally, such records will be stored and maintained in keeping with the official Records Control Schedule as set forth by the National Archives and Records Administration. For more information, please see
https://www.archives.gov/records-mgmt/rcs
.
Ill Person
We have modified the definition of
Ill person
under 71.1 to include a person who “(b)(2) Has a fever that has persisted for more than 48 hours; or (b)(3) Has acute gastroenteritis, which means either diarrhea, defined as three or more episodes of loose stools in a 24-hour period or what is above normal for the individual, or vomiting accompanied by one or more of the following: One or more episodes of loose stools in a 24-hour period, abdominal cramps, headache, muscle aches, or fever (temperature of 100.4 °F [38 °C] or greater).” This language was quoted verbatim in the preamble of the NPRM at 81 FR 54305 but was inadvertently omitted from the proposed regulatory text.
HHS/CDC received comments regarding the updated definition of
Ill person
which flight crews use to report to the CDC occurrences of illnesses in passengers or crew during travel. Specifically, commenters expressed concern that “non-medical personnel” such as flight attendants would report such observations; others questioned whether the definition is too broad and may result in over-reporting of non-threatening illnesses; others worried that it could lead to unnecessary apprehensions of individuals. One commenter claimed to be “chemical sensitive,” and worried that he or she may be penalized for having a reaction from sitting next to someone on a plane wearing a “strong fragrance.” HHS/CDC thanks the commenters for considering the proposal and providing feedback.
HHS/CDC clarifies that the purpose of the
ill person
definition is to align with current global and accepted detection and reporting practices so that onboard deaths and illnesses are reported by airlines and, where necessary, investigated by HHS/CDC. We note that the
ill person
definition in this final rule is consistent with the internationally recognized and accepted illness reporting guidelines published by the International Civil Aviation Organization (ICAO). This practice is not new, but has been used successfully for many years by aircraft and vessel crews to assist public health officials in preventing further transmission and spread of communicable disease.
HHS/CDC also does not intend to apprehend individuals based solely on their meeting the definition of an
ill person.
The purpose of an illness report is to allow trained HHS/CDC public health and medical officers to determine whether an illness occurring onboard a flight or voyage necessitates a public health response. In contrast, an apprehension of an individual is based on a variety of criteria in addition to an illness report including: Clinical manifestations, contact or suspected contact with infected individuals, host susceptibility, travel to affected countries or places, or other evidence of exposure to or infection with a quarantinable communicable disease. Thus, HHS/CDC disagrees that the ill person definition will lead to unnecessary apprehensions of individuals.
Several commenters noted that the symptoms listed in HHS/CDC's definition of an
ill person
are common symptoms of many non-threatening conditions, and thus questioned their inclusion in the definition. HHS/CDC appreciates the opportunity to respond to these concerns. The symptoms listed in HHS/CDC's
ill person
definition are provided for airlines and vessels to report to HHS/CDC so that HHS/CDC can make a public health risk assessment;
the symptoms alone would not result in issuance of a public health order.
In making such an assessment, HHS/CDC medical and public health officers consider the symptoms as well as the medical history of the person and any possible exposures that could indicate that the person may be infected with a quarantinable communicable disease.
A few commenters stated that the definition of
ill person
appears to expand the scope of HHS/CDC's authority beyond the list of quarantinable communicable diseases specified through an Executive Order of the President. HHS/CDC disagrees. The
purpose of the ill person definition is to help facilitate the identification, particularly by flight crews, of communicable diseases of public health concern. Thus, HHS/CDC has defined
ill person
in such a way that the term may be understood by non-medically trained crewmembers. While the reporting of an ill person onboard a flight may trigger a public health evaluation by a trained quarantine officer in consultation with an HHS/CDC medical officer, such reporting does not expand the basis upon which an ill person may be subject to apprehension, detention, or conditional release. As noted by the commenter, such public health actions are limited to those quarantinable communicable diseases specified through an Executive Order of the President (
e.g.,
cholera, diphtheria, infectious tuberculosis, yellow fever, viral hemorrhagic fevers, Severe Acute Respiratory Syndromes, and pandemic influenza).
A public health association suggested that any changes to the list of signs and symptoms within the definition of
ill person
should be made available for public comment. HHS/CDC assumes this comment is in reference to section (3) of the definition which provides for reporting of “symptoms or other indications of communicable disease, as the HHS/CDC may announce through posting of a notice in the
Federal Register
.” HHS/CDC appreciates the opportunity to clarify the purpose of this section. Section (3) of the
ill person
definition is intended to apply only to new, emerging, and imminent threats to public health. We expect it will only be relied on in emergency situations where a quick response is required to protect the public. Other circumstances, where the list of signs and symptoms may change due to evolving science or technology, will be made available for public comment, through a similar process as this rulemaking—Notices in the
Federal Register
—and may also request input from the public.
A number of commenters noted that symptoms listed in HHS/CDC's definition of an
ill person
are common symptoms of many conditions, particularly “appears obviously unwell” which many commenters requested be removed from the definition. HHS/CDC appreciates the opportunity to clarify that, with the exception of acute gastroenteritis on vessels, HHS/CDC only requires reporting of an ill traveler on an aircraft or vessel if
fever “accompanied by one or more of the following” other symptoms listed are present.
Therefore, as an example, headache alone would not be sufficient to require reporting, but rather fever plus headache, fever plus cough, fever plus persistent vomiting, fever plus persistent diarrhea, etc. These symptoms combined with fever are frequently seen in communicable diseases that could pose a public health risk to others during travel. Because a person with fever who also appears obviously unwell could have a serious communicable disease, HHS/CDC feels it is appropriate to retain this symptom, and further notes that its inclusion better aligns with Note 1 to the guidelines set forth by the International Civil Aviation Organization in paragraph 8.15 of Annex 9 to the Convention on International Civil Aviation.
One public health organization commented that the definition of
ill person
was broad and would be better issued through agency guidance rather than a rule. In response, HHS/CDC notes that the existing regulation contains an outdated and overly narrow definition of
ill person
that does not reflect current knowledge of communicable diseases, and that the reporting of ill travelers has been managed through a combination of regulation and agency guidance. This combination of “required” and “requested” reporting has proven confusing to some airline and vessel employees and this rule seeks to mitigate such confusion by including all relevant symptom clusters in the rule. Further, HHS/CDC notes that the change in the
ill person
definition better aligns with guidelines set forth by the International Civil Aviation Organization and is supported in comments received from the airline industry.
One public health organization commented on the different definitions of
ill person
for aircraft and vessels and recommended that the definitions be combined and not depend on the mode of transport. In response, HHS/CDC wishes to point out three crucial differences between aircraft and vessels which HHS/CDC feels justify the different definitions. One difference, additionally noted by the commenting organization, is the difference in time that a traveler spends on an aircraft and a vessel which makes the time frame (24 hours) specified in the definition of acute gastroenteritis for vessels relevant and minimizes the reporting of travelers with a single episode of loose stool that subsequently resolves, a common occurrence. The second is the high risk of spread of gastrointestinal infections onboard vessels that is unlikely to occur on aircraft; for this reason, reporting of diarrheal illnesses on aircraft includes the presence of fever which is more likely to indicate a serious communicable disease, whereas the definition on vessels includes diarrheal illness without fever to allow for the reporting of viral gastrointestinal illnesses that typically do not cause fever but have been known to cause large outbreaks on cruise vessels. The third difference is the presence onboard cruise vessels of medical facilities capable of making a diagnosis of pneumonia which allows the inclusion of pneumonia in the vessel definition. In all other respects, the definitions are the same. HHS/CDC adds that combining the definitions would be confusing to industry professionals responsible for conducting this reporting.
One public health organization provided a recommendation to modify the description of the “rash” component in the definition of ill person to ensure that the term fully encompassed the range of potential skin rash symptoms. The organization's recommendation for revisions was as follows: “The individual has areas on the skin that are red or purple, flat or bumps; with multiple red bumps; red, flat spots; or blister-like bumps filled with fluid or pus that are intact, draining, or partly crusted over; or dry and scaling patches. The rash may be discrete or run together, and may include one area of the body, such as the face, or more than one area.”
HHS/CDC responds that it will not change the regulatory text of the ill person definition with this language because we are concerned that this might add too much complexity to the regulatory definition. However, consistent with the regulatory definition of “ill person,” HHS/CDC will update its reporting guidance for aircraft and vessels to include this revised description. Current guidance may be found at:
http://www.cdc.gov/quarantine/air/reporting-deaths-illness/guidance-reporting-onboard-deaths-illnesses.html
.
An air industry commenter suggested another change to the ill person definition. The proposed definition included “headache with stiff neck,” and the commenter suggested that this be modified to “severe headache of recent onset with stiff neck.” While HHS/CDC will not change the regulatory definition of ill person to accommodate this change, HHS/CDC believes this is a useful modification to make in ill person reporting guidance to aircraft and vessels.
Incubation Period
HHS/CDC did not receive any comments on the proposed definition of
Incubation period.
However, upon a
review of the definition, we have decided that the definition should more closely track the definition of
Precommunicable stage.
For quarantinable communicable diseases, the
Incubation period
is defined as the
Precommunicable stage
of the disease. Thus, we have determined that the two definitions should more closely align. A substantive discussion of comments received concerning the definition of
Precommunicable stage
appears below.
Accordingly, we have modified the definition of
Incubation period
to add “or, if signs and symptoms do not appear, the latest date signs and symptoms could reasonably be expected to appear.” Other aspects of this definition are finalized as proposed.
Indigent
HHS/CDC received comments relating to the proposed definition of
Indigent
which is used to determine whether a detained individual qualifies for appointment at government expense of representatives to assist him/her during a medical review. One comment from a public health department suggested raising the threshold for indigent status to at least 200% of the applicable poverty guideline. HHS/CDC agrees and has made this change in the final regulation.
One commenter opposed including a definition for indigents and indicated that HHS/CDC should assume all costs whenever an individual is placed into Federal isolation or quarantine. HHS/CDC disagrees that assuming such costs without regard to indigence is necessary or appropriate.
Other substantive comments relating to the appointment at government expense of representatives to assist detained indigent individuals during a medical review are discussed below.
Master or Operator
HHS/CDC did not receive any comments on the definition of
Master or operator.
Accordingly, this definition is finalized as proposed.
Medical Examination
In response to comments received regarding medical examinations under sections 70.12 and 71.36, we have modified the definition of
Medical Examination
to indicate that the health worker conducting the assessment must be “licensed.” Comments regarding sections 70.12 and 71.36 are addressed below.
HHS/CDC received a comment regarding the definition of
Medical Examination.
The commenter stated that the definition of medical examination should include a mental health assessment because a mental health condition may impact an individual's appreciation of his or her public health risk to others. While HHS/CDC acknowledges that a mental health assessment may be useful as part of an individual's medical care and treatment and that such an assessment may be ordered as needed by a treating clinician, HHS/CDC declines to make such assessments a formal part of the medical examination process. Specifically, because a mental health assessment is not generally needed to diagnose or confirm the presence or extent of infection with a quarantinable communicable disease, HHS/CDC disagrees that it is necessary or appropriate to require such an assessment as part of a Federal public health order.
Medical Representative
HHS/CDC received several comments relating to the proposed definitions of
Medical Representative
and
Medical Reviewer
as well as the potential use of HHS/CDC employees as representatives or medical reviewers. One commenter suggested that it would be less problematic for HHS/CDC to allow and pay for outside participants to serve in these capacities. First, HHS/CDC notes that the definition of
Medical representative
has been changed to
Representatives
and revised as detailed below. HHS/CDC disagrees with this comment and notes that the definition of both
Representatives
and
Medical reviewer
would in fact allow for the appointment of non-HHS/CDC employees in these capacities as suggested by the commenter. For this reason, both
Representatives
and
Medical reviewer
are broadly defined in terms of the occupational qualifications of these individuals. HHS/CDC also does not consider it problematic to rely on internal reviewers and notes that it is not unusual, for instance, for hospitals to rely on internal decision-makers when determining whether to commit a mental health patient on an emergency basis.
HHS/CDC received a comment that the “definition of medical exemption is not apparent.” In response, HHS/CDC notes that no clarification of what is meant by “medical exemption” is provided by the commenter and that HHS/CDC did not propose adding such a definition. While these regulations do not authorize compulsory vaccination or medical treatment, there is no recognized “medical exemption” from quarantine, isolation, or conditional release and HHS/CDC declines to create one.
Non-Invasive
HHS/CDC received several comments concerning the definition of
Non-invasive,
including support from a public health association regarding the definition. However, several individuals disagreed with the proposed definition. In response to public comment that the definition of “non-invasive” allowed too much physical contact between the individual and public health officer, HHS/CDC has replaced “physical” with “visual” and removed “auscultation; external palpation; external measurement of blood pressure” from the definition. While HHS/CDC continues to believe that these procedures qualify as
Non-invasive
under the definition, after considering public comment and a review of standard operating procedures, HHS/CDC finds such procedures to be unlikely to be conducted during a public health risk assessment. Such procedures may be conducted at a port of entry by emergency medical service personnel as part of a medical assessment to determine the need for emergency medical care. We also modified the definition to clarify that the individual conducting the public health risk assessment will be a “public health worker.” Public health workers are individuals who have education and training in the field of public health.
One commenter mentioned that the new definition of
Non-invasive
states that the HHS/CDC could order laboratory testing under certain conditions. The commenter further asserted that forced laboratory testing, without the option of quarantine instead, is an invasive measure, and questioned how this could be in line with the concept of non-invasive. HHS/CDC responds that the definition of non-invasive applies to procedures conducted during a public health risk assessment at a port of entry and that this definition does not authorize forcible or invasive procedures to extract human biological samples for laboratory testing. Should laboratory testing be needed for a person reasonably believed to be infected with a quarantinable communicable disease, such testing would be done as part of a medical examination conducted at a healthcare facility and performed with the patient's informed consent. HHS/CDC has added language to the regulatory text requiring that the Director advise individuals of their right to have medical testing and examination conducted by an authorized and licensed health worker and with prior informed consent. While this regulation does not authorize forcible testing,
HHS/CDC may require laboratory test results demonstrating that a symptomatic individual is no longer infectious prior to rescinding a Federal isolation order.
Precommunicable Stage
HHS/CDC received comments relating to the definition of
Precommunicable stage.
One commenter suggested that persons in the “precommunicable stage” of a quarantinable communicable disease pose no direct threat to the public's health. A public health organization also stated that this definition should not apply to non-symptomatic people who have been exposed to Ebola. HHS/CDC disagrees with both comments. For instance, a patient diagnosed with multidrug-resistant or extensively drug-resistant tuberculosis who is not currently infectious, but who has not been adequately treated and is thus at high risk for relapse would be considered to be in the “precommunicable stage” of the disease and pose a direct threat to the public's health. Similarly, an individual who is reasonably believed to have been exposed to Ebola poses a direct threat.
Several public health organizations additionally expressed concerns regarding the use of the “precommunicable stage” definition to justify quarantine of healthcare workers caring for patients with quarantinable communicable diseases such as Ebola or severe acute respiratory syndromes, including healthcare workers providing care in the United States or in other countries. One such organization further requested clarification of whether the rule provides for the needs and protection of healthcare workers who voluntarily self-quarantine while providing care for patients with the quarantinable communicable diseases noted above.
In response, HHS/CDC states that it does not recommend quarantine or occupational restrictions of healthcare workers who follow recommended infection control precautions while providing care for patients with quarantinable communicable diseases. Healthcare workers who do not follow infection control precautions or who have had unprotected exposures to patients with a quarantinable communicable disease may be subject to quarantine or occupational restrictions; these individuals would be afforded the same due process protections as other exposed individuals.
Several commenters also questioned CDC's proposed definition for
Precommunicable stage
stating that it may result in an apprehension of an individual who displays no symptoms of a communicable illness. In response, HHS/CDC states that it has defined
Precommunicable stage
consistent with the public health practice of quarantine. Quarantine refers to the public health practice of separating and restricting the movement of individuals who are reasonably believed to have been exposed to a communicable disease, but are not yet ill. In contrast, isolation refers to the public health practice of separating and restricting the movement of individuals who have been exposed to a communicable disease and are symptomatic from those who are not sick.
The definition of
Precommunicable stage
is finalized as proposed.
Public Health Emergency
HHS/CDC received several comments relating to the definition of
Public health emergency.
One commenter stated that use of the term is duplicative and unnecessary because the term is used elsewhere in the Public Health Service Act (42 U.S.C. 247d) and appears in State-based legislation based on the Model State Emergency Health Powers Act. This commenter suggested that to avoid confusion the term should be renamed “Public Health Exigency.” HHS/CDC disagrees. Section 361(d) of the Public Health Service Act (42 U.S.C. 264(d)(1)) authorizes the apprehension and examination of individuals traveling interstate who are in the “precommunicable stage” of a quarantinable communicable disease, but only if the disease “would be likely to cause a public health emergency if transmitted to other individuals.” Thus, section 361(d) is unique and differs from how the term public health emergency is used in other statutes or provisions of the Public Health Service Act because it authorizes application of specific public health measures (apprehension and examination) to specific individuals (those in the precommunicable stage of a quarantinable communicable disease), but only if the disease would be likely to cause a public health emergency. Thus, HHS/CDC considers it essential to define public health emergency because the existence of such an emergency is a necessary prerequisite to the apprehension and examination of individuals in the precommunicable stage of a quarantinable communicable disease.
This commenter also suggested that the definition of public health emergency contains an oversight because it does not mention the potential for an infectious condition being highly likely to cause “short- or long-term disability.” HHS/CDC disagrees because the definition includes infectious diseases that are highly likely to cause “serious illness” if not properly controlled. HHS/CDC clarifies that “short- or long-term disability” caused by an infectious agent would be considered a “serious illness.”
This commenter further suggested that in addition to referencing a public health emergency declaration by the HHS Secretary, the definition should also include similar declarations by the President under the Stafford Act or under the National Emergencies Act. HHS/CDC disagrees. We note first that the definition of public health emergency is not limited to those emergencies declared by the HHS Secretary. Second, in the event of a man-made or natural disaster that also affects public health, the HHS Secretary may issue a separate declaration under the Public Health Service Act as was done in response to the terrorist attacks of September 11, 2001 and in response to Hurricane Katrina. Thus, HHS/CDC does not see a need to also reference Presidential declarations as suggested by the commenter.
This commenter also requested clarification concerning whether the World Health Organization's (WHO) declaration of a Public Health Emergency of International Concern (PHEIC) could continue to serve as the basis for a “public health emergency” if the President or HHS Secretary disagreed with the declaration of a PHEIC on legal, epidemiologic, or policy grounds. In response, HHS/CDC notes that the scenario proposed by the commenter is unlikely, but that CDC remains a component of HHS, subject to the authority and supervision of the HHS Secretary and President of the United States.
HHS/CDC also received a comment objecting to referencing the WHO's declaration of a Public Health Emergency of International Concern (PHEIC) in the definition of “public health emergency” because this ostensibly relinquishes U.S. sovereignty. HHS/CDC disagrees. By including references to a PHEIC, HHS/CDC is not constraining its actions or makings its actions subject to the dictates of the WHO. Rather, the declaration or notification of a PHEIC is only one way for HHS/CDC to define when the precommunicable stage of a quarantinable communicable disease may be likely to cause a public health emergency if transmitted to other individuals. While HHS/CDC will give consideration to the WHO's declaration of a PHEIC or the circumstances under which a PHEIC may be notified to the
WHO, HHS/CDC will continue to make its own independent decisions regarding when a quarantinable communicable disease may be likely to cause a public health emergency if transmitted to other individuals. Thus, HHS/CDC disagrees that referencing the WHO determination of a PHEIC results in any relinquishment of U.S. sovereignty.
The International Health Regulations are an international legal instrument that sets out the roles of WHO and State parties in identifying, responding to, and sharing information about public health emergencies of international concern. HHS/CDC believes that it would be unlikely for the United States to formally object to the WHO's declaration of a PHEIC, but that CDC remains a component of HHS, subject to the authority and supervision of the HHS Secretary and President of the United States.
Also regarding the definition of “public health emergency,” one public health association expressed concern that
any
disease considered to be a public health emergency may qualify it as quarantinable. Another commenter noted that some PHEICs “most certainly do not qualify as public health emergencies” under the proposed definition. HHS/CDC appreciates the opportunity to clarify. Only those communicable diseases listed by Executive Order of the President may qualify as quarantinable communicable diseases. For example, Zika virus infection, which although the current epidemic was declared a PHEIC by WHO, is not a quarantinable communicable disease. The definition of
Public health emergency
is finalized as proposed.
Public Health Prevention Measures
HHS/CDC received one comment relating to the definition of
Public health prevention measures.
The commenter stated that the second use of “and other non-invasive means” should be deleted from the definition of
public health prevention measures
as redundant. HHS/CDC disagrees because “observation, questioning, review of travel documents, and records review” as cited in the definition appears to materially differ from “other non-invasive means” that may be used as a part of public health prevention measures such as temperature checks, visual observation, or visual examination of the ear, nose, or mouth. Accordingly, HHS/CDC believes that the updated definition provides greater clarity as written. Further information, including a discussion regarding comments received on these proposed provisions, is discussed in the section below titled
Public Health Prevention Measures to Detect Communicable Disease.
The definition is finalized as proposed.
Qualifying Stage
HHS/CDC received several comments relating to
Qualifying stage.
Several commenters, including one public health organization, expressed concern that the definition was either too vague, too broad, or too confusing. One commenter suggested that the definition for
Qualifying stage
is confusing because it splits communicable diseases into a “precommunicable stage” and a “communicable stage” and that a communicable disease would not be on the list of Federal quarantinable communicable diseases if its spread did not already have some potential to cause a public health emergency. In response, HHS/CDC notes that the term “qualifying stage” is defined under 42 U.S.C. 264(d)(2) to include both a “precommunicable stage” and a “communicable stage” and that this definition explicitly references diseases “likely to cause a public health emergency.” Thus, while HHS/CDC may clarify and explain statutory terms through regulation, it has no authority to change the language of the statute.
One public health organization recommended that HHS/CDC policy implementing the
Qualifying stage
definition acknowledge that a one-size fits all protocol is not appropriate because different diseases have different transmission patterns and the need for isolation and quarantine may differ. HHS/CDC agrees that the need for isolation and quarantine may differ based on the disease and adds that it conducts a public health risk assessment before issuing Federal public health orders. For example, HHS/CDC does not typically issue Federal public health orders for cholera, a quarantinable communicable disease as defined by Executive Order because the sanitation infrastructure in the United States makes cholera transmission unlikely. HHS/CDC further notes that it typically conducts the public health risk assessment in coordination with the State or local health department of jurisdiction before issuing a Federal public health order.
Public health organizations and other commenters cautioned against apprehending individuals or issuing public health orders when the risk of communicable disease spread during the precommunicable period is low. HHS/CDC agrees and further adds that it will typically conduct a public health risk assessment in coordination with State and local public health officials to ensure that any restrictions imposed on an individual are commensurate with the degree of risk and using the least restrictive means available.
The definition of
Qualifying stage
is finalized as proposed.
Reasonably Believed To Be Infected, as Applied to Individuals
HHS/CDC received several comments regarding the definition of
Reasonably believed to be infected, as applied to an individual.
Several public health organizations expressed concern there could be undue burden placed on healthcare facilities or health departments by greatly expanding the number of individuals requiring health screening, medical examination and testing, or placed under Federal isolation of quarantine orders. HHS/CDC disagrees. This rule represents a codification of current practice and decisions regarding the need for medical examination of individuals suspected of being infected with a quarantinable communicable disease, including during an outbreak or public health emergency, will generally be based on published disease-specific case definitions for PUIs (persons under investigation) that incorporate clinical and epidemiologic factors. Furthermore, decisions regarding the issuance of Federal public health orders or medical examination for a suspected quarantinable communicable disease would typically be made in coordination with a State or local health department of jurisdiction. Therefore, HHS/CDC does not anticipate placing an undue burden on healthcare facilities or health departments as a result of these definitions.
One commenter stated that the
Reasonably believed to be infected, as applied to an individual
definition allows for apprehension, quarantine, or isolation based solely on reasonable inferences that the person was exposed somehow or in some way to infectious agents. HHS/CDC disagrees because as stated in the definition reasonable inferences may only be drawn from “specific articulable facts” that an individual has been exposed to an infectious agent such as through “contact with an infected person or an infected person's bodily fluids, a contaminated environment, or through an intermediate host or vector.” Thus, HHS/CDC disagrees that this standard does not comport with standard public health practice.
HHS/CDC received a comment from a public health agency expressing concern that travel to other countries where transmission of a quarantinable
communicable disease has likely occurred would be the sole basis upon which HHS/CDC would form a reasonable belief that an individual may be infected with a quarantinable communicable disease. In response, HHS/CDC clarifies that travel to other countries was simply used as an illustrative example. The decision to place an individual into isolation or quarantine will ordinarily be based on several factors, including travel, contact with an infected person or an infected person's bodily fluids, host susceptibility, and clinical manifestations. HHS/CDC believes that this definition is clear and that no further changes are necessary.
The definition of
Reasonably believed to be infected as applied to an individual
is finalized as proposed.
Secretary
HHS/CDC has added a definition for
Secretary
meaning the Secretary of Health and Human Services (HHS) or any other officer or employee of that Department to whom the authority involved has been delegated. We note that while the NPRM did not propose this definition, the NPRM referenced the
Secretary
in defining
Public Health Emergency.
Thus, HHS/CDC considers it useful to also define the term
Secretary.
After consideration of comments regarding
Definitions,
HHS/CDC has made the following changes in the final rule:
• The definition of
Agreements
has been withdrawn.
• The definition of
Conditional Release
under section 70.1 has been modified to remove the internal cross-reference to the definition of surveillance under section 71.1. The definition of
Conditional Release
under section 70.1 has been further modified to align with the definition of surveillance under section 71.1 and means “the temporary supervision by a public health official (or designee) of an individual or group, who may have been exposed to a quarantinable communicable disease to determine the risk of disease spread and includes public health supervision through in-person visits, telephone, or through electronic or internet-based monitoring.”
• The definition of
Electronic or internet-based monitoring
has been modified to indicate “communication through” such means, and include “audio” conference.
• The definition of
Incubation period
has been modified to add “or, if signs and symptoms do not appear, the latest date signs and symptoms could reasonably be expected to appear.” This aligns the definition with the
Precommunicable stage
definition.
• The definition of
Indigent
has been modified to increase the threshold to 200% of the applicable poverty guidelines.
• The definition of
Medical Examination
has been modified to indicate that the health worker conducting the assessment must be “licensed.”
• The definition of
Medical Representative
has been changed to
Representatives
and now includes in addition to the appointment of a medical professional, the appointment of “an attorney who is knowledgeable of public health practices.”
• The definition of
Non-invasive
has been modified to (1) replace “physical examination” with “visual examination,” (2) specify that the individual performing the assessment must be a “public health worker (
i.e.,
an individual with education and training in the field of public health)” and (3) remove “auscultation, external palpation, external measurement of blood pressure.”
• A definition for
Secretary
has been added and means “the Secretary of Health and Human Services (HHS) or any other officer or employee of that Department to whom the authority involved has been delegated.”
d. Public Health Prevention Measures To Detect Communicable Disease
HHS/CDC received support from commenters on screening individuals entering the U.S. from parts of the world where highly infectious diseases are common. One such commenter requested to know the criteria HHS/CDC uses when deciding whether to detain an individual. Another commenter stated that travel history “should be a prerequisite for Federal orders to quarantine” and “medical exam should be a prerequisite for Federal orders to isolate.” HHS/CDC thanks these commenters and welcomes the opportunity to explain this process.
HHS/CDC's decision to detain an individual is based on several criteria, including: Clinical manifestations: Signs and symptoms consistent with those of a quarantinable communicable disease; known or suspected contact with cases,
i.e.,
patients either confirmed or suspected to be infected with a quarantinable communicable disease; epidemiologic information/evidence (travel history, exposure to animals); other documentary or physical evidence in the individual's possession, such as a physician's note documenting infection with or medication for treatment of a quarantinable disease; and/or public health authorities having notified HHS/CDC that the individual is known or suspected to be infected with a quarantinable communicable disease and likely non-adherent with public health recommendations.
HHS/CDC has modified paragraph (b) of the provisions relating to public health prevention measures to detect communicable disease (§§ 70.10 and 71.20) to include information about “known or possible exposure,” in response to comments requesting further clarity of CDC's criteria.
One organization from the airline industry was generally supportive of 70.10 and 71.20,
public health prevention measures to detect communicable disease,
and requested that any measures, such as screening, occur prior to individuals boarding an aircraft, and preferably prior to arrival at the gate. HHS/CDC thanks these commenters for their support. In response, while an operational plan for each location has not yet been finalized, HHS/CDC expects such measures to occur prior to the boarding of an aircraft, and to the extent possible, prior to arrival at the gate. One airline organization insisted that airline operators should not be financially responsible for any costs associated with screening. HHS/CDC responds that it does not expect airlines and airline operators to assume direct costs associated with public health screening, such as providing additional personnel to conduct the screening. However, indirect costs such as missed flights of passengers who are detained may occur.
Another airline organization requested that HHS/CDC ensure wait-times in lines are not impacted by screening, and encouraged HHS/CDC to take into account the needs of all stakeholders. HHS/CDC feels strongly that in these rare circumstances, which would only occur should a threat to public health exist, preventing airline employees and other passengers from being exposed to a detained or delayed individual provides a greater benefit than the monetary loss of airfare. In keeping with current practice, HHS/CDC will work together with public health partners, carriers, and all who have equities, to ensure insofar as possible that the least restrictive and time-consuming measures are implemented. Finally, commenters requested that individuals who refuse to undergo a public health risk assessment prior to travel be denied boarding of an aircraft. In response, HHS/CDC notes that individuals may be denied boarding for public health reasons pursuant to the criteria published at 80 FR 16,400 (Mar. 27, 2015) titled
Criteria for Requesting
Federal Travel Restrictions for Public Health Purposes, Including for Viral Hemorrhagic Fevers.
HHS/CDC received a comment expressing concern about conducting public health prevention measures at “other locations” besides U.S. ports of entry because the commenter found this language vague. HHS/CDC clarifies that this term is meant to include all locations where individuals may enter the United States from a foreign country (
i.e.,
border crossings) or gather for the purposes of engaging in interstate travel (
e.g.,
airports, seaports, railway stations, bus terminals), regardless of whether such places are formally designated as such.
One public health organization requested clarification regarding what information or event would justify triggering the screening of travelers. CDC's response is that, while specific triggers cannot be defined at this time, screening of travelers may generally be conducted during a public health emergency if HHS/CDC determined that monitoring of potentially exposed travelers was needed to protect the public's health.
One public health organization and many individual commenters asserted that people exposed to measles should not be “tracked” through the use of Federal public health orders. First, we reiterate that because measles is not a quarantinable communicable disease, HHS/CDC does not have the authority to issue a public health order for this illness. Second, it is not HHS/CDC's policy to monitor people following measles exposures. Rather, HHS/CDC notifies State or local health departments regarding people in their jurisdictions who may have been exposed to measles. The State or local health departments, in turn, choose to notify people regarding their measles exposure, assess their immunity to measles and, if they are not immune, offer vaccination with MMR vaccine to prevent infection. State or local health authorities may choose to monitor people following exposures to measles based on their own criteria.
One commenter asked whether mandatory health screenings at airports would be conducted privately, whether processes would comply with HIPAA, and how data would be protected at airports. In response, HHS/CDC states that, in all situations, HHS/CDC strives to protect the privacy of individuals subject to screening, collection of information, or the issuance of Federal public health orders under HHS/CDC's authority. While some aspects of the entry risk assessment process conducted during the 2014-2016 Ebola epidemic were performed in areas of the airport that are not considered private, these were limited to collection of contact information, noncontact temperature measurement, observation for visible signs of illness, and superficial screening questions that did not collect sensitive information. Any more detailed public health assessment would be done in a private area.
HHS/CDC is bound by the Privacy Act to protect personally identifiable data collected and maintained in accordance with that Act. Furthermore, HHS/CDC will apply the protections of the SORN to all travelers regardless of citizenship or nationality. Personally identifiable data collected by HHS/CDC at airports are maintained in a secure database and shared only for official purposes on a need to know basis using secure methods as described in CDC's System of Records Notice published at 72 FR 70867. HHS is also a hybrid entity under HIPAA, but only those parts of HHS that have been determined to be health care components are subject to the HIPAA Privacy Rule. CDC is generally not a health care component treated as a “covered entity” under the HIPAA Privacy Rule. However, certain specific offices of HHS, CDC, and the National Institute for Occupational Safety and Health (NIOSH) performing activities related to the World Trade Center Health Program are considered health care components of HHS and must comply with HIPAA and the Privacy Rule.
One public health organization recommended that the rulemaking specify that individuals undergoing a public health risk assessment only be asked to provide contact tracing information if the risk assessment leads to a reasonable belief that the individual may become infected. It is CDC's policy to conduct conveyance-related contact investigations for confirmed cases of communicable diseases. In instances when confirmation cannot be obtained, HHS/CDC may investigate contacts based on reasonable belief of infection following a public health risk assessment which is typically conducted in coordination with the State or local health department of jurisdiction. Such operational details are generally defined in internal protocols. State or local authorities may conduct community-based contact investigations within their jurisdictions based on their own criteria.
After consideration of these comments, HHS/CDC has modified paragraph (b) the provisions relating to
Public Health Prevention Measures to Detect Communicable Disease
(§§ 70.10 and 71.20) to include information about “known or possible exposure” in the list of information that may be collected.
e. Apprehension and Detention of Persons With Quarantinable Communicable Diseases
HHS/CDC received several comments relating to the “apprehension” of an individual. One public health association and a public health department suggested that HHS/CDC not use the term “apprehension” because this may create social stigma. HHS/CDC uses this term in these regulations to align with the statutory terminology used in 42 U.S.C. 264(b) which authorizes the “apprehension, detention, or conditional release” of individuals coming into a State or possession from a foreign country or possession for purposes of preventing the introduction, transmission, and spread of quarantinable diseases. Similarly, 42 U.S.C. 264(d) authorizes the “apprehension and examination” of any individual in the qualifying stage of a quarantinable communicable disease who is moving or about to move between States or constitutes a probable source of infection to individuals moving between States. While HHS/CDC can clarify and explain this term, only Congress has the authority to change statutory language. In addition to being a term specifically used in statute under 42 U.S.C. 264, HHS/CDC has determined that this term best conveys that HHS/CDC may, based on public health grounds, assume physical custody of individuals. Furthermore, using alternative terminology, may reduce public understanding and transparency regarding HHS/CDC's legal authorities.
One commenter stated that not every social distancing technique needs to involve taking physical custody of individuals and that using more voluntary-based options would be advisable. HHS/CDC agrees that attempting to obtain voluntary compliance with public health measures is more advisable than assuming legal custody, but believes that maintaining the authority to apprehend individuals who may pose a public health risk is a necessary tool to protect the public's health. HHS/CDC received a comment regarding the “burden of proof” for an apprehension. In response, HHS/CDC notes that the applicable standard for an apprehension of an interstate traveler is “reason to believe” that the individual is in the qualifying stage of a quarantinable communicable disease. HHS/CDC notes that
Reasonably believed to be infected as applied to an individual
is defined under this final rule.
Several commenters expressed concern that because the “apprehension” period is not explicitly time-limited, that HHS/CDC may “apprehend” an individual indefinitely without providing the individual with a written public health order or a medical review. One commenter noted that HHS/CDC used the term “generally” in the preamble of the NPRM and felt it was too vague, stating “setting a firm timeframe is vital.” A partnership of public health legal scholars and organizations stated that because HHS/CDC did not explicitly limit how long an individual could remain apprehended that such apprehensions could turn into the functional equivalent of a quarantine thus potentially raising Fourth and Fifth Amendment concerns. In response to these concerns, HHS/CDC has added language requiring that it serve an apprehended individual with a public health order within 72 hours of that individual's apprehension.
HHS/CDC received several other comments relating to the sections authorizing the apprehension and detention of persons with quarantinable communicable diseases. A partnership of public health legal scholars and organizations suggested two public health frameworks for apprehension and detention, one for implementation during non-exigent circumstances and a second for exigent circumstances. As described, the primary distinction between the non-exigent and exigent framework, is that in the former HHS/CDC would be required to hold a due process hearing prior to the imposition of an isolation or quarantine, while in the latter HHS/CDC may briefly detain the individual prior to holding a hearing. While HHS/CDC appreciates the input provided by this partnership, HHS/CDC declines to adopt this suggestion. Importantly, unlike State and local public health authorities who have primary responsibility for the imposition of public health measures occurring within their jurisdictions, HHS/CDC acts in time-sensitive circumstances to prevent communicable disease spread, such as at ports of entry, upon the request of a State or local public health authority of jurisdiction, or when State or local control is inadequate. Furthermore, unlike State and local public health authorities who generally have broad police-power authority to protect the public's health, HHS/CDC's statutory authority with respect to isolation and quarantine is limited to only those small, subset of communicable diseases specified through an Executive Order of the President as quarantinable. Accordingly, HHS/CDC does not foresee sufficient “non-exigent” circumstances where it would be necessary for it to issue a Federal isolation or quarantine order and thus declines to establish the suggested alternative framework on this basis.
The circumstances under which HHS/CDC may apprehend and detain individuals is limited by the terms of 42 U.S.C. 264. HHS/CDC may only isolate, quarantine, or conditionally release an individual if it reasonably believes that the individual is infected with a quarantinable communicable disease and the individual is either arriving into the U.S. from a foreign country, moving between States, or constitutes a probable source of infection to others who may then move between States.
Accordingly, the circumstances under which CDC is would issue a quarantine or isolation order are “exigent” because the individual constitutes a communicable disease risk and is actively engaged in travel or constitutes a source of infection to others engaged in travel. It is thus unnecessary and impractical to provide a “pre-deprivation” hearing prior to quarantining or isolating the individual because he/she if released from custody may be lost to public health follow-up and may expose others. HHS/CDC would not quarantine or isolate an arriving traveler from a foreign country where a single case of a communicable disease such as Ebola exists unless it reasonably believes that the traveler arriving into the U.S. is infected with a quarantinable communicable disease.
Commenters stated that individuals must receive notice of their suspected exposure and be permitted to speak with legal counsel or have legal counsel appointed to them. HHS/CDC agrees that individuals should be adequately notified of the basis for their detention and directs this commenter to sections 70.14 and 71.37, which detail the specific factual content that must be included in a Federal order for quarantine, isolation, or conditional release. We have also modified these sections to explicitly require that the federal order include an explanation of the right to request a medical review, present witnesses and testimony at the medical review, and to be represented at the medical review by either an advocate (
e.g.,
family member, physician, or attorney) at the individual's own expense, or, if indigent, to have representatives appointed at the government's expense.
As previously stated, consistent with principles of preventing communicable disease spread, HHS/CDC will also take measures (such as ensuring phone access) to allow apprehended individuals to have contact with family or legal counsel whom they hire at their own expense. As explained further below, HHS/CDC will also appoint representatives, including a medical representative and an attorney, if the individual is indigent and requests a medical review. Individuals who do not qualify as indigent may also choose to be represented at the medical review by an advocate (
e.g.,
an attorney, physician, family member) and present a reasonable number of medical experts, of their own choosing and at their own expense. HHS/CDC, however, rejects as impractical the notion that indigent individuals should have representatives appointed to them
at the moment of apprehension
because most illnesses of public health concern can be ruled out based on a short interview with a quarantine officer involving an assessment of symptoms and travel history. Thus, the expected length of an apprehension will be very short and not justify the appointment of representatives.
This commenter also requested clarity on what legal recourse may be available to apprehended individuals. While HHS/CDC does not express an opinion regarding what form of legal action an aggrieved individual should pursue, we note that these regulations do not impact the constitutional or statutory rights of individuals to seek judicial redress for detention.
HHS/CDC received comments from the public regarding HHS/CDC's authority to “arrest” individuals. One commenter stated that individuals should only be detained when a crime has been committed. One association objected to HHS/CDC's “power to detain an individual for 72 hours and longer without any Federal court order.” Some commenters also worried that any person showing signs of a “common cold” may be held. To be clear, HHS/CDC is not a law enforcement agency, it has no legal authority to “arrest” individuals, but rather has been granted the authority by Congress to “apprehend and detain” individuals for the purposes of preventing the introduction, transmission and spread of quarantinable communicable disease as specified in an Executive Order of the President. 42 U.S.C. 264(b). This provision further provides that “regulations may provide that if upon examination any such individual is found to be infected, he may be detained for such time and in such manner as may be reasonably necessary.” 42 U.S.C. 264(d)(1). HHS/CDC strongly believes that these
authorities may be implemented in a manner consistent with the U.S. Constitution. Furthermore, during the period of apprehension, HHS/CDC will arrange for adequate food and water, appropriate accommodation, appropriate medical treatment, and means of necessary communication.
HHS/CDC received comments from the public inquiring about the criteria that HHS/CDC uses to determine whether an individual should be detained and assessed. As provided for in the regulation, HHS/CDC may apprehend, examine, isolate, and quarantine such individuals to protect the public's health. In determining whether an individual poses a threat to public health, HHS/CDC has developed and uses the following criteria: Clinical manifestations: Signs and symptoms consistent with those of a quarantinable disease; known or suspected contact with a case,
i.e.,
patients either confirmed or suspected to be infected with a quarantinable disease; epidemiologic information/evidence (travel history, exposure to animals); other documentary or physical evidence in the individual's possession, such as a physician's note documenting infection with or medication for treatment of a quarantinable communicable disease; and/or public health authorities have notified HHS/CDC that the individual is known or suspected to be infected with a quarantinable communicable disease and non-adherent with public health recommendations. This determination is typically made in consultation and coordination with State and local public health authorities, as well as the treating health care physician (when available). One public health association agreed that travel history (entering the U.S. from a country where quarantinable diseases occur) made sense for screening, but not for a quarantine or isolation order. HHS/CDC responds that the criteria listed above, as well as those within the NPRM, are examples of factors that HHS/CDC takes into consideration when determining the totality of the circumstances—not one criterion does, should, or will, decide if the individual requires a public health order.
One commenter questioned whether, regarding the list of quarantinable communicable diseases listed by Executive Order of the President, a “common cold” would qualify as a “severe acute respiratory syndrome” and therefore subject the ill individual to a public health order. In response, we note that Executive Order 13295 (April 4, 2003), as amended by Executive Order 13375 (April 1, 2005) and Executive Order 13674 (July 31, 2014), explicitly excludes “influenza” from the definition of severe acute respiratory syndrome.
HHS/CDC received several comments from a flight attendant union relating to apprehension and detention of a flight crew. These comments include that the flight attendant's employer should be made aware of the apprehension, that HHS/CDC should limit the personal health information that is shared with the employer, that the employer should treat this information as confidential, and that those apprehended should be able to notify families and their union. In response, HHS/CDC notes that it works closely with the airline industry regarding potential occupational exposures to communicable diseases. Furthermore, HHS/CDC notes that personally identifiable health information collected and maintained under the Privacy Act will be disclosed only with the consent of the subject individual, in accordance with the routine uses published in HHS/CDC's system of records notice (72 FR 70867), or under an applicable exception to the Privacy Act. While these regulations do not mandate how employers should treat the personal health information of their employees, HHS/CDC agrees that such information should be treated as confidential. Lastly, consistent with principles of preventing communicable disease spread, HHS/CDC will allow persons detained in accordance with these regulations to communicate with family, union representatives, legal counsel whom they hire at their own expense, and others of their choosing. HHS/CDC will also appoint representatives, including a medical representative and an attorney, if the individual is indigent and requests a medical review.
One commenter asked about provisions for people detained under HHS/CDC's authority who require emergency medical care, and whether the need to conduct a public health assessment could impede such care resulting in harm to the individual. In response, HHS/CDC states that public health officers at ports of entry work closely with emergency medical service (EMS) personnel and that emergency medical care takes precedence over the public health risk assessment. When an individual suspected of being infected with a quarantinable communicable disease requires emergency care, the individual would be transported immediately by EMS to a medical facility, using appropriate infection control precautions. The public health risk assessment would be completed subsequently using information provided by the examining health care provider in coordination with the health department of jurisdiction.
After consideration of these comments, HHS/CDC has finalized the
Apprehension and Detention of Persons With Quarantinable Communicable Diseases
(§ 70.6) provision as proposed, with the exception that Federal public health orders must be served on the individual within 72 hours of an apprehension. As further detailed below, the 72-hour period was determined based on public comment from health departments familiar with the process, as well as CDC's previous experience of the time necessary to conduct a medical examination, collect and package laboratory specimens, transport the specimens to an appropriate laboratory (when necessary), and conduct the testing.
f. Medical Examinations
HHS/CDC received several comments relating to medical examinations. HHS/CDC received a comment from a public health agency stating that when an individual agrees to submit to a medical examination, it may be more appropriate to medically examine the patient during the “apprehension” period. In response, HHS/CDC notes that these regulations do not prohibit voluntary compliance with public health recommendations in the absence of a public health order. Notwithstanding, HHS/CDC believes that the ability to order a medical examination as part of an order for isolation, quarantine, or conditional release is an important tool to protect the public's health. This agency also stated that the definitions of “health status” and “public health risk” should be modified to ensure that the medical examination contains the minimum requirements needed to assess the communicable disease of public health concern. In response, HHS/CDC clarifies that its sole purpose in ordering a medical examination would be to determine the presence, absence, or extent of infection with a quarantinable communicable disease. HHS/CDC notes, however, that the medical examination is conducted by clinical staff who have primary responsibility for the patient's medical care and treatment and that a medical examination would thus ordinarily include the taking of a medical history and physical examination. HHS/CDC believes that this definition is clear and that no further modifications are needed.
HHS/CDC received a comment expressing concern that an individual would not be able to choose his or her own clinical healthcare provider if
ordered to undergo a medical examination. One commenter raised concerns about the possibility of medical examinations being conducted by “unqualified” or “non-medical personnel.” In response, HHS/CDC clarifies that, in keeping with current practice, any medical evaluation required by HHS/CDC would be conducted at a healthcare facility by a licensed healthcare practitioner. Furthermore, HHS/CDC has determined that it would be impractical to allow individuals to choose their own medical examiners. HHS/CDC notes that among other considerations, it must ensure that the healthcare facility where the medical examination will be conducted has appropriate containment facilities, that necessary laboratory samples will be properly collected, and that it is HHS/CDC's practice to coordinate closely with State and local public health authorities in the choosing of clinical healthcare providers. Accordingly, we have concluded that the public interest is best served by having HHS/CDC, in coordination with the local health authority and EMS, choose the healthcare facility where the medical examination will be conducted and not the detained individual.
One commenter expressed concern that nonmedical personnel may be allowed to make a determination of illness resulting in actions being taken based on potential misdiagnosis. HHS/CDC appreciates the opportunity to clarify this point. Decisions to issue Federal public health orders are based on the assessment of qualified and licensed physicians. These decisions are based on all available evidence, including clinical presentation, medical and exposure history, and the results of medical evaluation and laboratory testing. Treatment decisions are made by the individual's treating physician with guidance from public health subject-matter experts.
One commenter suggested that medical examinations should be conducted only with the informed consent of the individual and should not “forcibly” be required. HHS/CDC clarifies that it may require a medical examination under 42 U.S.C. 264(d) because this section, among other things, authorizes the “apprehension and examination” of individuals reasonably believed to be infected with quarantinable communicable diseases in a qualifying stage. CDC, however, agrees that medical examinations may not be conducted “forcibly.” Furthermore, because medical examinations will typically occur in a hospital setting and be performed by clinical staff, it will be incumbent upon clinical staff to obtain the patient's informed consent consistent with established standards of medical practice.
Public health organizations provided several comments regarding medical examinations, including that they be performed promptly so as not to curtail liberty, include only minimal components necessary to establish the diagnosis of or rule out the quarantinable communicable disease of concern, and that specimens obtained during such examinations not be used for purposes other than diagnostic testing without informed consent. In response, HHS/CDC states that it agrees with all of these points and that CDC, in keeping with current practice, has a commitment to upholding the highest ethical standards for both medical care and research.
One public health organization asked for clarification of whether hospital staff would be involved in obtaining consent for medical examinations authorized under this rule. In response, HHS/CDC states that, while a public health order authorizes that a medical examination be conducted, should any invasive procedures be determined by the treating clinician to be necessary for diagnostic or treatment purposes, consent for such procedures should be obtained by medical staff in accordance with established standards.
One organization asked for clarification of the location where medical examinations would be conducted, including whether inpatient or ambulatory-care facilities would be included. HHS/CDC responds that it will coordinate with State or local health departments of jurisdiction concerning such operational details as the exact locations where medical examinations may be conducted.
Several public health organizations commented on whether the issuance of public health orders is needed prior to medical examination if individuals agree voluntarily to such examinations, noting that a requirement for the issuance of orders could impede or delay the medical examination and that the examination, itself, could determine whether such orders are needed. In response, HHS/CDC notes that it may choose not to exercise its authority to issue public health orders if an individual complies voluntarily with HHS/CDC's requirements, including the requirement of a medical examination. However, HHS/CDC retains the right to issue an order requiring a medical examination should an individual not comply voluntarily. Of note, one public health organization supported the use of Federal public health orders in requiring medical examinations, stating that such orders had been used effectively in the past to facilitate timely examination.
One public health organization requested that language be added to the rule stating that medical examinations will be performed with proper adherence to worker safety and health policies and protocols. HHS/CDC responds that such occupational health protections are beyond the scope of this regulation and are covered by regulations of the Occupational Safety and Health Administration (OSHA).
HHS/CDC received several comments from a flight attendant union relating to medical examinations. This organization stated that the regulations should mandate that an employer pay a flight attendant's salary and per diem and that no flight attendant should incur discipline as a result of being absent from work. This organization further commented that any changes in the employer-employee relationship should be addressed through joint guidance between government and industry groups. This group also commented that “promptly” should be defined in terms of the length of time that may be needed to arrange for a medical exam and that no more than five hours would be reasonable. This group further stated that “reasonably believed” should be defined to require specific, articulable facts that a trained medical professional can articulate.
HHS/CDC responds that these regulations do not alter, define, or mandate the employer-employee relationship between flight attendants and their employers. In regard to the timeframe for arranging a medical examination, HHS/CDC rejects a specific 5-hour timeframe as too prescriptive, but agrees that the medical examination should be arranged as quickly as possible based on the circumstances of the event. HHS/CDC further notes that the definition of “reasonably believed to be infected” already requires th
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